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Inclusion Criteria: * Black/of African Descent * Pregnant (gestational weeks ≤ 28 weeks) * Age 18-45 * English proficient * Receiving services in 1 of 4 study sites above * Low-income: i.e., receiving Medicaid * Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety) * Able to provide consent Exclusion Criteria: * age \<18 * Currently under the influence of a substance(s) * Experiencing psychosis * Critical (clinical) risk: actively suicidal or homicidal * Not Black/of African Descent * Planning to deliver outside DC

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study * 44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause transition (Stages of Reproductive Aging Workshop (STRAW stage -1). * Anhedonia or psychosis symptoms that began during the period of menstrual irregularity. * Clinician's Global Impression Scale-Severity score (CGI-S) \> 3 to confirm a clinically impaired sample. * Anhedonia severity inclusion criteria and stratification: All participants will have Snaith-Hamilton Pleasure Scale (SHAPS) scores \> 20 consistent with the NIMH Fast-Fail Trial for Mood and Anxiety Disorders, corresponding to clinically impairing anhedonia. * Psychosis severity inclusion criteria and stratification: Participants will be stratified according to scores on the psychotic subscale of the Brief Psychiatric Rating Scale (BPRS) * Willingness to adhere to the estradiol regimen Exclusion Criteria: * Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®. * BMI \< 18 or \> 35 kg/m\^2 * A history of chronic menstrual cycle irregularity, meaning \> 1 year without menses * MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100% plastic. * PET contradictions: participation in \>1 research study in the past 12 months that included ionizing radiation exceeding 3 rem to the whole body (e.g., PET, CT). Standard of care imaging is not exclusionary. * The use of psychotropics or hormonal preparations. * History of psychiatric illness during the 2 years before the onset of perimenopause. * History of chronic, recurrent mood or psychotic disorders (i.e., more than one non-reproductive-related mood episode prior to the perimenopausal index episode). * A history of mood episodes requiring hospitalization. * Current mania; * Depressive episode(s) within 2 years of enrollment not associated with the transition to menopause; * A history of suicide attempts within the last year or current active suicidal ideation with intent and plan. * Neurological conditions (e.g., history of seizure or TBI) * Brain stimulation treatment in the past six months. * Endometriosis; * First degree relative with premenopausal breast cancer or breast cancer presenting in both breasts or multiple family members (greater than three relatives) with postmenopausal breast cancer. * Current medication use (i.e., current psychotropics, current anti-hypertensives, current statins, current hormonal preparations, or frequent use of anti-inflammatory agents (\> 10 times/month)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (\< 5 times/month) use of Ambien)\*; * Pregnant, breastfeeding or trying to conceive; * Last menstrual period more than 12 months prior to enrollment; * History of undiagnosed vaginal bleeding; * Undiagnosed enlargement of the ovaries; * Polycystic ovary syndrome; * History of breast or ovarian cancer; * First degree relative with ovarian cancer; * Abnormal finding in a provider breast exam and/or mammogram; * Known carrier of BRCA1 or 2 mutation; * Porphyria; * Malignant melanoma; * Hodgkin's disease; * Recurrent migraine headaches that are preceded by aura; * Gallbladder or pancreatic disease\*\*; * Heart or kidney disease\*\*; * Liver disease; * cerebrovascular disease (stroke); * First degree relative with history of heart attack or stroke; * Current nicotine use; * Self-reported claustrophobia * Peanut allergy * all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment; * participants will be given the opportunity to describe these conditions in the online screening survey. Reported conditions that are acute in nature and/or benign will be reviewed by a study physician and exclusions will be decided case-by-case. All chronic conditions will be exclusionary. For those where it is deemed that an exclusion does not apply, primary analyses will not be affected, but exploratory analyses will be conducted excluding these individuals

Inclusion Criteria - Patients will be included if they: 1. provide written informed consent before initiation of any study-related procedures 2. are outpatients 3. meet the DSM-5 criteria for major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features as confirmed at Screening by the Mini International Neuropsychiatric Interview (MINI) 4. are male or female, 18 to 65 years of age (inclusive) at screening 5. have a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 20 (moderate to severe depression) at screening 6. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening 7. able to adhere to the treatment schedule 8. pass the TI adult safety screening questionnaire 9. are able to understand and comply with the requirements of the study, as judged by the investigator(s) Exclusion Criteria - Patients will be excluded if they: 1. have an acute alcohol or substance use disorder, withdrawal symptoms requiring detoxification, or went through detoxification treatment (inpatient or outpatient) within 3 months before Screening, as obtained from MINI, Module I (Alcohol Use Disorder) and Module J (Substance Use Disorder, Non-Alcohol) assessed at Screening 2. have a concomitant major unstable medical illness, active hepatitis B virus (HBV), hepatitis C virus (HPC), human immunodeficiency virus (HIV), active COVID-19 infection, cardiac pacemaker or implanted medication pump, as per medical history provided by the participant 3. have active suicidal intent, confirmed by a 'Yes' response to Question B3 AND either Question B10 or B11, obtained from the MINI Suicidality, Module B (Suicidality), OR confirmed by the MADRS item #10 score ≥ 4, both assessed at Screening 4. have a current clinical diagnosis of autism, dementia, or intellectual disability 5. take medications prohibited by the protocol. Medications will be reviewed by the responsible MD 6. are pregnant or lactating 7. have any prior or current diagnosis of bipolar I or II disorder, MDD with psychotic features, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms as obtained from MINI, Module C (Manic and Hypomanic Episodes) and Module K (Psychotic Disorders and Mood Disorders with Psychotic Features) assessed at Screening 8. have any prior or current diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), confirmed by MINI and assessed by a study investigator to be primary and causing greater impairment than MDD 9. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD 10. have received TI for any previous indication due to the potential compromise of subject blinding 11. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space-occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes, current history of poorly controlled migraines including chronic medication for migraine prevention 12. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed 13. if participating in psychotherapy, have NOT been in stable treatment for at least 3 months prior to entry into the study or anticipate change in the frequency of therapeutic sessions or therapeutic focus over the duration of the study 14. have a clinically significant laboratory abnormality, in the opinion of one of the principal investigators or study physicians 15. currently take medications that potentially limit the TI efficacy 16. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with an interview) 17. have a clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina) 18. have uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism will be excluded if they have NOT been on a stable dose of the medication for 30 days prior to enrolment 19. have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measure 20. wear a hairstyle or headdress at the time of the stimulation that prevents electrode contact with the scalp or would interfere with the stimulation (e.g., thick or curly hair) 21. have any contraindications for receiving TI or undergoing MRI scans (e.g., hip circumference \>180 cm or metal in the body)

Study Population Operable stage IV breast cancer patients, whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imaginology examination Inclusion Criteria: * Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination. * ECOG-PS 0-2. * Bone marrow, liver and kidney should be fully functional. * Patients didn't received the locoregional surgery of the primary tumor in de novo. * For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed. Exclusion Criteria: * Accompanied with other primary malignant tumors. * More than two visceral organ involvement. * Patients who can't plan for follow-up effectively and regularly. * Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).

Inclusion Criteria: 1. Have histologically or cytologically confirmed diagnosis of neoplasia 2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion. 3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section. 4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting. 5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible. 6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 7. Age ≥ 18 years and ≤ 70 years. 8. Patient is able to understand and willing to sign a written informed consent. 9. Clinical performance status of ECOG 0, 1 or 2. 10. HLA-A\*0201or A\*0206 positive. 11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment. 12. Women of child-bearing potential must have a negative pregnancy test. 13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. 14. Hematology * ANC \> 1500/mm3 without the support of filgrastim * WBC ≥ 3000/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off. 15. Chemistry * Serum ALT/AST ≤ 2.5 x ULN * Creatinine clearance ≥40ml/min * Total bilirubin ≤ 1.5 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL. * INR \< 1.5 Exclusion Criteria: 1. Women of child-bearing potential who are pregnant or breastfeeding. 2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses 4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. 5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin. 6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months. 7. Subjects unable to maintain normal oxygen saturation level in room air. 8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria: * Have been on a stable dose of anticoagulation for \< 1 month (except for acute line insertion induced thrombosis). * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement). 9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy). 10. LVEF ≤ 40% 11. Documented FEV1 ≤ 60% predicted tested in patients with: * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years). * Symptoms of respiratory dysfunction. 12. Patients who are at the time of study initiation receiving any other investigational agents. 13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above. 14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

Inclusion Criteria: * Non-specific invasive carcinoma diagnosed by biopsy * X-ray images available * Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically * Patient with a breast size compatible with the study bra size Exclusion Criteria: * Contralateral breast cancer * Inflammatory breast cancer * History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling) * History of breast cancer or mastectomy * Presence of dermatological pathology or breast skin ulceration * Hematoma post biopsy * History of thoraco-abdominal radiotherapy * Known allergy to one of the materials of the device * Fever (body temperature \> 37.8°C) * Pacemaker port

Inclusion Criteria: 1. Self-declared diagnosis of hematological cancer on stable maintenance management\* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks) 2. Not currently participating in a therapeutic pharmacologic clinical trial 3. Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks) 4. Score of \>5 on PSQI (Pittsburgh Sleep Quality Index) 5. Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection 6. Willing to download two mobile apps 7. Able to read/understand English 8. ≥18 years of age 9. Willing to be randomized 10. Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period) 11. Taking sleep medications and/or over-the-counter sleep drugs/supplements (if any) on fewer than 3 nights per week and one of the following: 1) willing to maintain the same intake without change throughout the study time frame (i.e., 20 weeks) or 2) willing to discontinue if intake is prescribed "as needed" (PRN) by a physician throughout the study time frame (i.e., 20 weeks) Exclusion Criteria: 1. Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months 2. Reside outside of the United States of America 3. Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes) 4. Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire) 5. Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week 6. Any other diagnosed and uncontrolled medical or psychiatric condition 7. Has a pacemaker 8. Shift work schedule

Inclusion Criteria: * Korean woman who is 45 years or older * Does not currently have a breast cancer diagnosis * Non-adherent to cancer screening (did not receive mammogram in last 2 years based on self-report) * Prospective or current member of participating Korean Churches * Willing to participate in study Exclusion Criteria: * Does not meet inclusion criteria as described above

Inclusion Criteria: 1. Age: 18-70 years old; 2. clinically diagnosed type 2 diabetes. 3. Glycosylated hemoglobin: 6.5% - 9.5%; 4. No drug treatment or only one oral hypoglycemic drug within 6 months; 5. Fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication; 6. if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months. 7. Body mass index (BMI) ≤ 45 kg / m2; 8. Sign informed consent Exclusion Criteria: 1. patients with type 1 diabetes; 2. diabetic complications (ketoacidosis, hypertonic state, lactic acidosis). 3. Allergic to the study drug; 4. Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L); 5. Complicated with other serious organ diseases; 6. Recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure; 7. Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker; 8. Baseline QT interval extension (male \> 450ms or female \> 460ms); 9. Treatment with class IA or class III antiarrhythmic drugs; 10. Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.); 11. Participating in other clinical trials within 3 months; 12. Other circumstances that the investigator considers unsuitable for participating in this clinical study.

Inclusion Criteria: 1. The singleton pregnant women aged from 19 to 50 years 2. Includes at least one factors of the below ① History of preeclampsia ② History of fetal growth restriction ③ History of intrauterine fetal death 3. Women who have agreed to enroll in the study and given their informed consent Exclusion Criteria: 1. Indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignancy (However, the participation of the trial is allowed by the investigator based on medically necessary.) 2. Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies) 3. Major malformation of the fetus is diagnosed at 11-13 weeks of gestation 4. Elevated blood concentrations of creatinine more than double the normal value 5. Elevated blood concentrations of liver transaminases (AST(GOT) or ALT(GPT)) more than three times the normal value 6. Conditions related with aspirin treatment * Previous exposure within 28 days of screening * Previous NSAID exposure within 28 days of screening * Bleeding disorder (von Willebrand's disease, peptic ulceration) * Hypersensitivity to aspirin 7. Conditions related with hydroxychloroquine treatment * Previous exposure within 28 days of screening * Hypersensitivity to hydroxychloroquine and 4-aminoquinoline compounds * Maculopathy * Medications that has potential for visual disturbance * Women who have potential for changes in the retina or visual impairment by 4-aminoquinoline compounds * Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption * Prolonged QT interval on EKG (congenital or acquired) or The risk factors of QT prolongation (heart failure, arrhythmia, myocardial ischemia) * Low level of potassium in the blood * Low level of magnesium in the blood 8. Not suitable for participant based on medical evidence by investigator

Inclusion Criteria: * adult patients (\>18 years) with a major depressive disorder who will either start with ECT or medication * failed response to at least 1 adequate dose-duration trial with antidepressants * moderate or severe depression (HDRS-17 \>16) Exclusion Criteria: * lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome * the presence of a concurrent significant medical condition impeding the ability to participate

Inclusion Criteria: 1. Self-identify as African American 2. 50 years of age or older 3. Diagnosed with hypertension, with a systolic blood pressure≥ 130 mmHg but less than 170 mmHg 4. Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication 5. Own a smartphone with a data plan, the capability to download the Medisafe app, or view videos 6. Able to read/understand English Exclusion Criteria: 1. Unable to give informed consent or judged to have impaired cognitive ability or severe memory 2. Currently using a medication management application (app) 3. Experienced a major CVD event or procedure (e.g., myocardial infarction, stroke, heart surgery) within the past year 4. Patients with a diagnosis of chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2) and/or receiving dialysis.

Inclusion Criteria: 1. Signed informed consent 2. Voluntary admission to the psychiatric ward prior or directly after the screening point 3. Age: 18-65 on the day of screening 4. Meeting DSM-5 criteria for a depressive episode in Bipolar Disorder type I or type II, as confirmed by the Mini International Neuropsychiatric Interview (MINI) 5. Displaying a sum score of ≥10 on the Bech 6-item subscale of the Hamilton Depression rating Scale. 6. Treatment with a stable dose of a mood stabilizer since at least 4 weeks before screening: lithium s-conc\> 0,45 mmol/L; \>lamotrigine dose 100 mg/d; \>valproate dose \> 900 mg/d, \>carbamazepine concentration \>20 mmol/L 7. In female patients of childbearing potential: negative result of a pregnancy test and a method of contraception with a failure rate of less than 1 %. Women of childbearing potential must, for inclusion, use a highly efficient method of contraception, i.e. a method with a failure rate of less than 1% (e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomy in partner). 8. Male patients must agree to use condoms during the study and for 2 weeks after the end of the study/last dose of IMP, unless their partner is using a highly efficient method of contraception, as described above. Exclusion Criteria: 1. Ongoing compulsory care. 2. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. 3. Previously diagnosed or meeting MINI criteria at interview for obsessive-compulsive disorder or post-traumatic stress disorder. 4. A previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability. 5. A history of substance/alcohol abuse within 2 years prior to screening. 6. Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial (such as dementia, brain injury, and epilepsy). 7. Young Mania Rating Scale (YMRS) total score of \>12 at screening or at any time during the trial. 8. Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial. 9. Any signs or symptoms of somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests or 12- lead ECG that according to the investigator renders the patient unsuitable for participation for safety reasons, including a QTc-time on ECG exceeding 450 ms in men and 460 ms in women. 10. Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc. 11. Any change in medication (including dosage) of an antidepressant drug or a mood stabiliser within 4 weeks prior to screening or at any time during the trial. 12. Ongoing treatment with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazol, itraconazole, telitromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine). 13. Ongoing treatment with drugs displaying a narrow therapeutic window - with the exception of lithium - where either reduced or increased serum levels are potentially harmful (including but not limited to warfarin, other anticoagulants, digoxin. other antiarrythmics, anticonvulsants when prescribed for treatment of epilepsy but not when prescribed for bipolar disorder, cyclosporine, and immunosuppressants). 14. Ongoing treatment with drugs with dopaminergic synapses as primary site of action (e.g., antipsychotics, bupropion, central stimulants, and drugs for Parkinson's disease). 15. No observed beneficial effect of treatment and a symptom severity that by the investigator's assessment would render continued participation unethical. 16. Previous intake of OSU6162. 17. Current participation in another clinical trial. 18. Nursing women.

Inclusion Criteria: 1. Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures. Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent) 2. Male (≥18 years old) or pre-menopausal women (≥40 years old) or post-menopausal women. Premenopausal/male patients will receive LHRH agonists 2 weeks before C1D1 and during treatment. Post-menopausal status is defined as: 1. Age ≥60 years or 2. Age \<60 years and 12 months of amenorrhea plus follicle stimulating hormone (FSH) and plasma estradiol (E2) levels within post-menopausal range by local laboratory assessment or 3. Prior bilateral oophorectomy (≥7 days prior to Day 1 of treatment). 3. Histologically confirmed invasive breast carcinoma, confirmed by the local pathologist, with all the following characteristics: 1. Clinical stage II (Seventh Edition of the AJCC) which includes cT1cN1cM0, cT2cN0cM0, cT2cN1cM0 and cT3cN0cM0. 2. ER-positive/HER2-negative according to the most recent ASCO/CAP guidelines assessed locally, tumor cells \>10% ER staining, grade 2 or 3 breast cancer. 3. Ki-67 index by local analysis of ≥20% on untreated tumor tissue and/or high genomic risk (defined by gene signature): Oncotype DX® RS ≥ 26, Mammaprint® = Risk of Recurrence High, Prosigna® ROR ≥ 60 or luminal B, or Endopredict® = Risk of Recurrence High. Note: Multifocal and multicentric tumors are permitted if they are considered clinical stage II according to Seventh Edition of the AJCC. Biopsy of all lesions is not necessary. 4. Breast cancer eligible for primary surgery. 5. Available pre-treatment FFPE core (tru-cut) biopsy evaluable for PAM50 or possibility to obtain one. Minimal sample requirements are to have at least 1 tumor cylinder with a minimal tissue surface of 4 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 μm each (the quality of the sample must be approved centrally prior to inclusion). 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the date of enrolment. 7. Adequate hematological, renal and hepatic function, as follows: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L 2. Platelet count ≥100 x 109/L 3. Hemoglobin ≥10 g/dL 4. Alkaline phosphatase (AP) ≤2.5x upper limit of normal (ULN) 5. Total bilirubin \<ULN. Patients with known Gilbert syndrome may be enrolled with total bilirubin ≤3 x ULN or direct bilirubin ≤1.5 x ULN. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5x ULN 7. Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault Equation) 8. Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within institutional normal limits or corrected to within normal limits with supplements before first dose of study medication. Male participants: 8. A male participant must agree to use a contraception as detailed in Appendix 1 of this protocol during the adjuvant chemotherapy period (only non-responder cohort) and for at least 21 days, corresponding to time needed to eliminate any study treatments plus an additional 120 days (a spermatogenesis cycle) after the last dose of chemotherapy and refrain from donating sperm during this period. After the end of trial treatment, patients should use effective contraception according to local guidelines. Female participants: 9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies (see Appendix 1): 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 1 during the treatment period and for at least 21 days (corresponding to time needed to eliminate any study treatments) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment. After the end of trial treatment, patients should use effective contraception according to local guidelines. Exclusion Criteria: 1. Any prior treatment for primary invasive breast cancer. Letrozole or other drugs used during the preservation of ovarian function are permitted if administered after baseline biopsy. 2. Inoperable breast cancer. 3. Patients with Stage I, III or IV breast cancer are not eligible. Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice (in patients where there may be a reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms). If performed, reports of these examinations must be available. Examination type for staging, i.e. X-ray, sonography, bone scan, CT, MRI, and/or PET-CT, is at the discretion of the investigator. 4. Bilateral invasive breast cancer. 5. Patients who have undergone sentinel lymph node biopsy prior to study treatment. 6. Inability or unwillingness to swallow pills. 7. Malabsorption syndrome or other condition that would interfere with enteric absorption of study drugs. 8. Participation in a prior investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational product, whichever is longer. 9. Patient with a Child-Pugh score B or C. 10. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: 1. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening. 2. History of documented congestive heart failure (New York Heart Association functional classification III-IV). 3. Documented cardiomyopathy. 4. Patient has a Left Ventricular Ejection Fraction (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO). 5. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block). 6. Long QT Syndrome or family history of idiopathic sudden death or congenital long QT syndrome or any of the following: 7. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia. 8. QTc \>500 msec or conduction abnormality in the previous 12 months. 9. On screening 12-lead ECG, any of the following cardiac parameters: bradycardia (resting heart rate \<50), tachycardia (resting heart rate \>90), or QTcF interval ≥450 msec (using Fridericia's correction). 10. Uncontrolled hypertension (Systolic blood pressure \>160 mmHg or \<90 mmHg and/or diastolic \>100 mmHg). 11. Active infection requiring intravenous (IV) antibiotics. 12. Prior story of pneumonitis of any cause. 13. Prior thromboembolic events not attributable to a clear trigger cause. 14. Known human immunodeficiency virus (HIV) infection. 15. Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may compromise compliance with the protocol, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications. 16. Significant traumatic injury within 3 weeks prior to initiation of study treatment. 17. Major surgical procedure (not including minor pro

Inclusion Criteria: Subjects eligible for this study must meet all of the following criteria: 1. Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer. 2. Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label. 3. Patients who are willing to provide written informed consent Exclusion Criteria: Subjects eligible for this study must not meet the following criteria: 1. Patients with contraindication according to prescribing information for Piqray in Korea. \- Severe hypersensitivity to Piqray or to any of its components 2. Female subjects who are pregnant and nursing (lactating) 3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray. 4. Participants who receive or are going to receive any investigational medicine during surveillance period.

Inclusion Criteria: \* The patient must be considered eligible for treatment at the NSAC by the admission team at the NSAC. Exclusion Criteria: * Patients considered too healthy for treatment at the NSAC, i.e. not within target group * Patients considered too sick for treatment at the NSAC, i.e. not within target group * Patients that do not have a diagnosis that is relevant for treatment at the NSAC, i.e. not within target group * Patients otherwise considered not within target group for the measure * Patients which were included in the NSAC Nudge trial (clinicaltrials identifier: NCT05006976) may not be recruited within the first year of follow-up of that trial * Patients which are secondary referred from other departments/clinics within the hospital * Non-Norwegian or non-English speaking patients * Patients which could not be reached by the research coordinator at the outpatient clinic for information about the study

Inclusion Criteria: 1. Male or Female \>18 years of age on the day of informed consent signing. 2. Progression on a CDK4/6 inhibitor in combination with an AI immediately prior to the enrollment on this study 3. Histologically confirmed ER-positive, HER2-negative metastatic breast cancer. ER-positive is defined as ≥1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show: * IHC 1+ or 0 * In situ hybridization negative based on: * Single-probe average HER2 copy number \<4.0 signals/cell * Dual-probe HER2/CEP17 ratio \<2.0 with an average HER2 copy number \<4.0 signals/cell. 4. Measurable disease according to the RECIST 1.1 or bone-only disease. 5. Postmenopausal status or receiving ovarian ablation with a gonadotropin-releasing hormone (GnRH) agonist. Postmenopausal status is defined by any one of the following criteria: * Prior bilateral oophorectomy * Age ≥55 years * Age \<55 years and amenorrheic for at least 12 months (spontaneous cessation of menses for 12 consecutive months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone and estradiol levels in the postmenopausal range without an alternative cause If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a GnRH agonist, the patient is eligible for this trial, provided that the GnRH agonist is started at least 2 weeks prior to the first dose of trial treatment. 6. Eastern Cooperative Oncology Group performance status of 0 or 1. 7. Life expectancy ≥6 months. 8. Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy). Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 21 days is required between end of radiotherapy and randomization. 9. Adequate organ function: * Absolute neutrophil count ≥1500/µL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility) * Platelets ≥100,000/µL (without transfusion within 2 weeks of laboratory test used to determine eligibility) * Hemoglobin ≥9 g/dL (without blood transfusion) * White blood cell count \>2,500/µL and \<15,000/µL * Lymphocyte count ≥500/µL * Serum bilirubin ≤1.5x upper limit of normal (ULN; patients with known Gilbert's disease who have serum bilirubin level ≤3 x ULN may be enrolled) * Serum transaminases (aspartate transaminase \[AST\] or alanine transaminase \[ALT\]) activity ≤3.0 x ULN with normal alkaline phosphatase (\[ALP\]; patients with liver metastases ≤5 x ULN) OR AST and ALT ≤1.5 x ULN with ALP \>2.5 x ULN * International normalized ratio and activated partial thromboplastin time ≤1.5 x ULN * Serum creatinine at or below the institutional normal value. 10. Able to swallow oral medication. 11. Patients who are made postmenopausal through use of GNRH agonists must be willing to use an adequate method of contraception for the course of the trial through 1 year after the last dose of trial treatment. 12. Patients who are made postmenopausal through use of GNRH agonists should have a negative serum pregnancy (β-human chorionic gonadotropin) within 7 days prior to trial treatment administration. 13. Willing and able to provide written informed consent/assent for the trial. Exclusion Criteria: 1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration. 2. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent. Note: If the patient received major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the trial treatment. 3. The patient has had major surgery within 14 days prior to starting the study. 4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 5. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 8. Concurrent use of strong cytochrome P450 (CYP)3A inhibitors or inducers. 9. Hypersensitivity to fulvestrant, abemaciclib, or any of their excipients. 10. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason. 11. Has a bleeding disorder or currently taking anticoagulants. 12. Has active hepatitis B (detectable hepatitis B surface antigen) or active hepatitis C infection (detectable hepatitis C RNA). 13. Has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment. 14. Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. 15. Documented brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Patients with previously diagnosed brain metastases are eligible if they have completed treatment at least one month prior to trial treatment administration, are neurologically stable, and have recovered from effects of radiotherapy or surgery. * Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥2 weeks before trial treatment administration. * Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, or a combination as was deemed appropriate by the treating physician. * Patients who meet the above criteria and are clinically stable on anticonvulsant medication are eligible only if their anticonvulsant does not alter hepatic CYP activity in a way that might interfere with the metabolism of abemaciclib. 16. Have received any live vaccination within 28 days of trial treatment administration. 17. History within the last 12 months of any of the following conditions: syncope of cardiovascular

Inclusion Criteria: 1. Males and females aged 18-65 years (inclusive) 2. Body mass index (BMI) 18-35 kg/m2, inclusive 3. Normal blood pressure or well managed hypertension (systolic blood pressure \<160mmHg, diastolic blood pressure \<100 mmHg) 4. Confirmed diagnosis of T2DM (by repeated laboratory findings) for at least 1 year. 5. Subjects under glycemic control on a stable dose of metformin (within the standard of care dose range up to 2 g daily) for at least 2 months prior to enrolment or those who manage their condition only by diet/exercise. 6. For subjects on a stable dose of concomitant metformin for at least 2 months prior to enrolment, the subject's dose of metformin will be required to remain constant until at least the completion of MMTT on the final dosing day. Subjects whose concomitant glucose lowering medication changes during the dosing phase of the study will be discontinued and may be replaced. 7. For subjects not in receipt of concomitant metformin for at least 2 months prior to enrolment, and who manage their condition only by diet/exercise, documentation of stable glycemic control under current condition management for at least 2 months prior to enrolment, as confirmed by HbA1c. For subjects who meet this criterion, no change in disease management is permitted until at least the completion of MMTT on the final dosing day. Any subject who requires a change in disease management, including initiation of any diabetes medication during the study, will be discontinued from the study and may be replaced. 8. Fasting plasma glucose ≥5.6 mmol/L at screening 9. HbA1c ≥6.5% and ≤9.0% at screening 10. Vital signs after 10 minutes resting supine: 1. 90 mmHg \<systolic blood pressure \<160 mmHg 2. 40 mmHg \<diastolic blood pressure \<100 mmHg 3. 40 bpm \<heart rate \<100 bpm Duplicate assessments will be performed and the average of the two assessments of blood pressure will be used. 11. Standard 12-lead ECG parameter results at screening, after 10 minutes resting in supine position, within 120 ms \<PR \<220 ms, QRS \<120 ms, QTcF ≤450 ms (males), QTcF ≤470 ms (females). 12. No history of significant cardiovascular disease over the preceding 3 years or any other major disease other than T2DM and well managed hypertension, unless permitted at the discretion of the PI. 13. Negative test for selected drugs of abuse at screening (does not include alcohol) and at admission (testing at admission does include alcohol breath test). A positive result may be verified by re-testing (up to one false positive result permitted) and may be followed up at the discretion of the PI. 14. Females must be non-pregnant and non-lactating, and either surgically sterile for a minimum of 6 months (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptives pills, long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device \[IUD\]) from screening until study completion, or be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (≥ 40 IU/mL) at screening for amenorrheic female subjects. Females who are abstinent from heterosexual intercourse will also be eligible. 15. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study. 16. Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the subject and his partner must be surgically sterile (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP), as per Inclusion Criterion #14. Male subjects whose female partner is post-menopausal, and subjects who are abstinent from heterosexual intercourse will also be eligible. Male subjects must agree to refrain from donating sperm from screening until study completion. Exclusion Criteria: 1. Pregnant or lactating, or intending to become pregnant within 30 days after last dose of study drug. 2. Participation in a clinical trial within 30 days before enrolment; use of any experimental oral therapy within 30 days or 5 half-lives prior to enrolment, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to enrolment, whichever is greater. Subjects who have received an experimental therapy that has no half-life, such as a vaccine, should have completed that therapy at least 30 days prior to enrolment. 3. Any vaccine 2 weeks prior to first study drug administration until 2 weeks after the last dose, with the exception of current seasonal influenza vaccination. 4. Use of any weight loss agent within the preceding 4 weeks. 5. Surgery or hospitalization during the 4 weeks prior to screening. 6. Planned procedure or surgery during the study. 7. Blood transfusion within 8 weeks prior to screening. 8. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥ 300 mL of blood within 30 days prior to study drug administration. 9. Poor peripheral venous access. 10. Alcohol and/or substance abuse or dependence within the past 2 years. 11. Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g. myocardial infarction, angina pectoris, New York Heart Association Class II or more cardiac failure). 12. History of pancreatitis 13. History or presence of an abnormal ECG that is clinically significant in the PI's opinion and/or evidence of prior myocardial infarction within 2 years before screening. 14. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g. hypokalemia, hypomagnesemia, hypocalcaemia), or family history of sudden unexplained death or long QT syndrome. 15. Impaired hepatic function as indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 x or total bilirubin ≥ 1.5 x the upper limit of normal (ULN), which remains above these limits if retested due to a slightly elevated initial result or abnormalities in synthetic function tests that are judged by the PI to be clinically significant. 16. Unstable hypo- or hyperthyroidism. 17. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome Type 2. 18. Current or history of bulimia or anorexia nervosa. 19. History of severe allergy (requiring hospital care), severe reaction to any drug, or any known or suspected allergies or sensitivities to the study drug constituents. 20. Diagnosis with Type 1 Diabetes Mellitus (T1DM) or any previous episodes of diabetic ketoacidosis. 21. History of or ongoing inflammatory bowel disease or diabetic gastroparesis. 22. Severe hypoglycaemia resulting in seizure/unconsciousness/coma/hospitalization in the last 3 months before screening. 23. Persistent hyperglycaemia not controlled by metformin/diet/exercise. 24. Proliferative retinopathy, nephropathy or renal impairment (\<60 mL/min as calculated by the CKD-EPI equation) if deemed clinically significant by the PI. 25. Any other serious medical condition, or abnormality in clinical laboratory tests, that would preclude the subject's safe participation in and completion of the study or increase the expected risk of exposure to the investigational product (IP) or would be expected to interfere with the planned evaluations, in the judgment of the PI. 26. Use of diabetes medic

Inclusion Criteria: * invasive breast cancer confirmed by biopsy and histology; * based on prone CT scan and Doppler ultrasound, axillary stage cN2-3; * agree and meet the requirements for NAC; * meet surgical requirements and agree to undergo surgery after NAC; * the regime of NAC follows the NCCN recommendations. Exclusion Criteria: • previous history of breast cancer or other malignant tumors.

Inclusion Criteria: * Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression * No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC * Eligible for taxane monotherapy * A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. * Eastern Cooperative Oncology Group performance status of 0 or 1 * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and end-organ function Exclusion Criteria: * Known central nervous system (CNS) disease, except for asymptomatic CNS metastases * Leptomeningeal disease * Pregnancy or lactation * History of autoimmune disease * Prior allogeneic stem cell or solid organ transplantation * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment