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Inclusion Criteria: 1. Be ≥ 18 years of age. 2. Have signed informed consent. 3. Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy: * Patients with persistent disease and local recurrence must not be amenable to local treatment. * For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories: 1. Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen. 2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy. 3. Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings. 4. Cancers with known germline or genomic actionable targets, e.g. g/mBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated. 5. HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients. 6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens. 7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided: * The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose) * There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose * Tumor is not impinging on Middle Cerebral Artery/speech-motor strip * If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose 4. Has expected survival of at least 4 months. 5. ECOG performance status of 0, 1 or 2 Exclusion Criteria: 1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose. 2. Radiotherapy within 14 days of the first dose of study treatment. 3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). 4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), . 5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies. 6. History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM. 7. History of hypersensitivity to any of the therapies proposed for treatment in this study. 8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>2.0 × ULN or \<30 mL/min for participants with creatinine levels \>2.0 × institutional ULN. 9. Absolute granulocyte count \<1000; platelets \<80,000; hemoglobin ≤ 7 g/L. 10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>3x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary. 11. INR or PT or aPTT \> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. 12. Receiving any medication listed in the prohibited medication section of the protocol. 13. Proteinuria \>2+ on urinalysis 14. A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds. 15. New York Heart Association stage 3 or 4 cardiac disease. 16. A pericardial effusion of moderate severity or worse. 17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. 18. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment. 19. Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study. 20. Women who are pregnant or nursing. 21. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent. 22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS. 23. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. 24. Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed. 25. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization). 26. Active infections requiring systemic therapy within the past 14 days. 27. Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor. 28. Has received a live vaccine within 28 days of the first dose of study drug. 29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.

Inclusion Criteria: * Laboratory values meeting the criteria laid out in the protocol. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization \[WHO\] criteria). Participant meets the criteria for disease activity laid out in the protocol. Exclusion Criteria: * Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. * Unresolved clinically significant AEs \> Grade 1 from prior anticancer therapy. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol. * History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol. * Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required. * History of other active malignancy, with the exception of those laid out in the protocol. * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.

Inclusion Criteria: * Women age ≥ 45 * Clinical T1-2N0 ER+ invasive breast cancer * US detected biopsy proven axillary nodal disease * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Palpable nodes on physical exam * Her2+ or ER- invasive breast cancer * Extranodal extension \> 3 mm on nodal biopsy * More than 2 suspicious nodes on preoperative imaging

Teachers Inclusion Criteria: * Teaching in recruited schools. * At least 18 years old. Parents Inclusion Criteria: * At least 18 years old. * Have a child aged 6-14 years. Exclusion Criteria: * Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study. * Parents/Teachers/Caregivers who are not in one of our recruited primary school * Participants under the age of 18 * Participant who does not speak English and Luganda will not be able to participate

Inclusion Criteria: * Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category) * Require inpatient stabilization for SI or actions based on clinical observation and interview * Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus * Have a Glasgow Coma Score (GCS) of 15 * Age 18-65 Exclusion Criteria: * Current or past history of psychosis * Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater * History of ketamine use disorder * History of liver transplant * Pregnancy or breastfeeding * Imprisonment or inability to consent * Positive urine drug screen or serum alcohol level * Hypertension (SBP \> 160 or DBP \> 100 before administration of ketamine) * Hypotension (SBP \< 90) * Presence of acute medical condition requiring admission to medical service * Allergy, intolerance, or previous adverse reaction to ketamine * Patient has 8+ lifetime ketamine exposures * The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)

Inclusion Criteria: * Sex: Men and women are eligible. * Age: Individuals aged 20-75 years old are eligible. * Ethnicity: Bahraini adults of all ethnic groups are eligible for the study. * Type 2 diabetes and glycaemic control: Individuals with controlled type 2 diabetes (i.e. HbA1c \<9 on medication) based on the medical record of each patient's last visit to the health centre for routine follow-up will be eligible if within the last four months. Otherwise, these measurements will be ordered at the first visit to confirm eligibility. * Blood pressure: Individuals whose blood pressure is under moderate control will be eligible - specifically, treated or untreated resting systolic/diastolic pressure \< 160/100 mmHg. * Lipid control: Individuals with fasting triglyceride concentration \< 600 mg are eligible. Exclusion Criteria: * HbA1c \>9% * Type 1 diabetes * Taking insulin * Pregnancy * Non-ambulant or severely incapacitated with any medical condition(s) reducing ability to stand or mobilize. * Currently participating in a study to reduce sedentary behaviour or increase physical activity * Language. Inability to read and understand Arabic or English language. * Inability to give informed consent.

Inclusion Criteria: * Men and Women aged ≥ 18 years * Signed informed consent * Apart from hypertensive retinopathy, normal ophthalmic findings * Non-Smokers * Patients with initially diagnosed or pre-existing mild to moderate primary arterial hypertension (systolic office blood pressure ≥ 140 mmHg and/or diastolic office blood pressure ≥ 90 mmHg) * Planned initiation of antihypertensive medication or planned adaption of antihypertensive medication by the Department of Cardiology * Subject agrees to perform regular blood pressure self-measurements and to document blood pressure values in a diary Exclusion Criteria: * Participation in a clinical trial in the three weeks preceding the study * Blood donation in the three weeks preceding the study * Symptoms of a clinically relevant illness in the three weeks preceding the study * History of family history of epilepsy * Secondary hypertension (e.g.: hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal diseases, Cushing-syndrome, Coarctatio aortae) * History of hypertensive encephalopathy or intracerebral bleeding * Diabetes mellitus Type 1 or Type 2 * Pregnant or breast-feeding women * Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception

Inclusion Criteria: * Patients ≥ 18 years of age; * Patients with confirmed leading diagnosis of asthma with or without concomitant COPD; * Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum); * Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Inclusion Criteria: * The study will enroll adult persons with breast cancer or colorectal cancer or no cancer (healthy controls) who are able to do a fasting blood draw. (Pregnant women may choose to be in the study. The study procedures do not pose a risk to the safety of the unborn child or the woman.) Exclusion Criteria: * The study will not enroll persons who are unable or unwilling to provide informed consent. * Adults unable to consent, individuals who are not yet adults, and prisoners will be excluded from this study.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Any patient older than 18 years 4. Scheduled for elective surgery requiring general anesthesia 5. Presenting with hypertension during the pre-operative assessment (defined as either a systolic blood pressure \> 140 mmHg or a diastolic blood pressure \> 90 mmHg Exclusion Criteria: 1. Known adverse reaction to clevidipine or any of its constituent parts. 2. Presence of structural heart disease. 3. Known acute or chronic kidney disease. 4. Pregnancy or lactation. 5. Non-elective surgery. 6. Treatment with another investigational drug or other intervention at the time of enrollment. 7. Patients unable to consent for themselves. 8. Incarcerated patients. 9. Known defect in lipid metabolism.

Inclusion Criteria: 1. Subject is willing and able to provide written informed consent. 2. Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures. 3. Subject is a pregnant female before 22 weeks of gestation 4. Subject is at least 18 years of age Exclusion Criteria: 1. Estimated due date (EDD) via 1st or 2nd ultrasound, date of last menstrual period (LMP), or in-vitro fertilization (IVF) implantation date is not available 2. Subject is pregnant with multifetal gestation (e.g., twins) 3. Subject is planning to deliver via home birth

Inclusion criteria: * Identical haplo CSH donors ascending (parents) or descending (children) * Major identical haplo HSC donors * Haplo-identical HSC donors living in mainland France and cared for in the centers participating in the study * Haplo-identical HSC donors benefiting from Social Security System. * Haplo-identical HSC donors who have signed the consent form * \- Ability to read and write in French Exclusion Criteria: \- Insufficient understanding of the French language

Inclusion Criteria: * Patients aged ≥ 18 years * Ability to understand and the willingness to sign a written informed consent. * Indication for breast biopsy for diagnostic purposes * ECOG performance status of 0 to 3. Exclusion Criteria: * Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

Inclusion Criteria: I• Age ≥ 18 years of age at time of consent * ECOG performance status 0, 1, or 2 * Histologically confirmed invasive breast cancer documented by biopsy or surgical excision. * Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically positive margins are eligible if adjuvant radiotherapy is planned), with most recent breast or axillary surgery \< 90 days prior to date of signed consent. * No evidence of distant metastatic disease * No prior systemic therapy for this cancer other than pre-operative endocrine therapy * Treating Oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy. Patients may receive a CDK4/6 inhibitor after completion of all study treatment, concurrently with adjuvant endocrine therapy. Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment. * Tumor is estrogen receptor (ER)-positive (\> 10% by IHC) and/or progesterone receptor (PR)-positive (\> 10% by IHC), HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines. * AJCC pathologic stage: o pT1-3/pN0-2 based on sentinel lymph node biopsy or axillary dissection * High risk gene expression profile (either luminal B on MammaPrint/BluePrint, or Recurrence Score \> 25 on Oncotype Dx). Study participants are not required to have a high-risk gene expression profile if they have a clinical high-risk tumor, defined as: Age \< 50 and any of the following: * Involvement of 1-3 axillary lymph nodes with metastatic carcinoma (pN1mic/N1) * grade 1 tumor \> 3 cm; or grade 2 tumor \> 2 cm; or grade 3 tumors \> 1 cm (size based on pathological assessment of the maximal dimension of the invasive component of the tumor) * pT1c-T2 and Ki-67 \> 20% * Presence of lymphovascular invasion stage IIIA (pT3/pN1 or pT1-3/pN2) Age \> 50 and any of the following: * Primary tumor \> 5 cm (pT3) * stage IIIA (pT3/pN1 or pT1-3/pN2) * Adequate organ function as defined in Table 1. All screening labs to be obtained within 30 days prior to registration. * Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the CMC regimen is appropriate therapy for all primary tumors requiring chemotherapy. * Able to provide written informed consent and HIPAA authorization for release of personal health information. * Women of childbearing potential must agree to use 2 methods of birth control, at least one being a barrier form of contraception if they are sexually active with a male partner unless they are considered highly unlikely to conceive as defined in section 8.6, and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. * As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study. * Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the CMC regimen (see Appendix), and either of the following criteria are met: * Patients without a history of AIDS-defining opportunistic infections. * Patients with a history of AIDS-defining opportunistic infections, but they have not had an opportunistic infection within the past 12 months. * Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in CMC (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria. * Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in CMC. Exclusion Criteria Subjects meeting any of the criteria below are ineligible for this study: * Prior cytotoxic chemotherapy for this breast cancer * Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy * AJCC stage IIIB-IIIC or stage IV * Active infection requiring systemic therapy * Untreated HIV/AIDS * Documented DYPD deficiency * Pregnant or nursing * Require anticoagulation with warfarin. Anticoagulation with low molecular weight heparins, heparin, or direct oral anticoagulants (DOACs) is permitted. * Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist. * Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial. * Other major comorbidity (e.g. advanced cardiopulmonary disease, uncontrolled diabetes mellitus) that may affect the safety or efficacy assessment of this investigational regimen, as determined by study PI * Inability to swallow pills * Any medical condition interfering with absorption of oral medications * Any contraindication for any chemotherapy drug used in the CMC regimen * Active and ongoing use of medicines known to alter metabolism or tolerability of component drugs in CMC. * Prisoners * Unable or unwilling to take a large number of oral pills

Inclusion Criteria: * 1\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form. 2\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female. 3\. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+. 4\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage. 5\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status. 6\. Documented radiographic disease progression (during or after the most recent treatment). 7\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 8\. Expected survival ≥ 3 months. 9. ECOG score of 0 or 1 within 14 days prior to administration. 10. Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent. 11\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria. 12\. Have sufficient elution of previous treatment before administration. Exclusion Criteria: * 1\. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis. 2\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration. 4\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed. 5\. Previous use of antibody conjugates containing topoisomerase I inhibitors. 6. There is a third gap fluid that cannot be controlled by drainage, etc. 7. Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy. 8\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug. 9\. Previous or current autoimmune disease. 10. Have uncontrolled comorbidities. 11. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0). 12\. History of previous immunodeficiency. 13. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation. 14\. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.

Inclusion Criteria: * Diagnosed with stage I-IIIA breast cancer * Completed primary treatment, including surgery, radiotherapy and/or chemotherapy * Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy * Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise * FACT-Cog questionnaire score ≥ 10th percentile considering age groups * Fluency in Spanish (spoken and written) Exclusion Criteria: * Undergoing radiotherapy and/or chemotherapy * FACT-Cog questionnaire score ≤ 10th percentile considering age groups * Congenital heart disease * Chronic lung disease * Severe psychiatric disorders * History of substance abuse, or dependence (other than tobacco) * Mood disorders require treatment (anxiety or depression) * Relapses (2-3 months before the study start)

Inclusion Criteria: * \> 18 years old * BCLM * BCLM and extra-hepatic disease * Any treatment * Ability to understand and sign the informed consent Exclusion Criteria: * Inability to provide the informed consent * Patient who underwent Best Supportive Care or Palliation

Inclusion Criteria: * Histological pathological confirmation of primary breast cancer or metastatic disease. * Hormonal receptor-positive, HER2 negative. * Metastatic breast cancer at presentation (Den novo) or recurrent. * Patients did not receive any previous systemic therapy for metastatic disease. * Performance status (ECOG) 0-2. Exclusion Criteria: * Patient with co-morbidity * Pregnant and breast lactating women

Inclusion Criteria: * Participants must be at least 18 years of age * no history of allergic disease (healthy controls), have clinically diagnosed allergies, or have clinically diagnosed asthma. Exclusion Criteria: * Pregnant women and prisoners will be excluded from the study. * Individuals currently suffering from any acute infections and those known to suffer from light-headedness will be excluded.

Inclusion Criteria: 1. ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer 2. All patients, independent from gender 3. ≥18 years at diagnosis 4. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes. 5. Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population, per investigator´s decision) 6. No clinical evidence for distant metastasis (M0) 7. Tumour block available for central pathology review 8. Performance Status ECOG ≤ 1 or KI ≥ 80% 9. Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients 10. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements 11. The patient must be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up 12. Laboratory requirements: * Leucocytes ≥3.5 109/L, * Neutrophils \> 1.5 109/L, * Platelets ≥100 109/L, * Haemoglobin ≥10 g/dL, * AP \< 5.0 ULN, * AST ≤2.5 x ULN, * ALT ≤2.5 x ULN, * Total bilirubin ≤1 x ULN, * Creatinine ≤1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN 13. Clinical assessments: • LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment) 14. The following age-specific requirements apply: * Women aged \<50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site. * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments. 15. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization/study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. 16. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. 17. Female patients must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study. 18. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period. Exclusion Criteria: 1. Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs 2. Prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri 3. Any history of invasive breast cancer 4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor 5. Concurrent treatment with other experimental drugs 6. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry 7. Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment 8. Breast feeding woman 9. Reasons indicating risk of poor compliance 10. Patients not able to consent 11. Known polyneuropathy ≥ grade 2 12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric/substance abuse disorders, acute cystitis, ischuria, and chronic kidney disease 13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals 14. History of pneumonitis 15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC). 16. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded. * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. * Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease. 17. Patients who test positive for HIV antibody.