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About This Study

This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.

Design

Interventions / Regimen

• Other: MARVIN — Chatbot on Meta (Facebook) Messenger for HIV Patients
• Other: MARVIN-Pharma — Chatbot on Meta (Facebook) Messenger for community pharmacists
• Other: MARVINA — Chatbot on Meta (Facebook) Messenger for breast cancer patients
• Other: MARVIN-CHAMP — CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)

Primary Outcomes

• Usability Metric for User eXperience (UMUX-Lite) (Immediately, after 1-month of testing - objective 2)
• Acceptability E-Scale (AES) (Immediately after 1-month of testing - objective 2)
• Change in Acceptability E-Scale (AES) over 12 months (Once every 3 months within 12 months)
• Change in Intervention Appropriateness Measure (IAM) over 12 months (Once every 3 months within 12 months)
• Change in Compatibility Subscale over 12 months (Once every 3 months within 12 months)

About This Study

This is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatment (RT) for breast cancer.

Design

Interventions / Regimen

• Diagnostic Test: Magnetic Resonance Imaging Simulation — Radiographic Image Simulation

Primary Outcomes

• Percentage of participants who completed scan (Day of MR imaging (1 day))

About This Study

This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.

Design

Interventions / Regimen

• Drug: SC-101 — Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).

Primary Outcomes

• cORR (Baseline (Day -28 to Day -1); tumor response will be evaluated every 8 weeks (±7 days) from the first dose of study treatment to the data cut-off date, up to 24 months.)

About This Study

Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.

Design

Interventions / Regimen

• Drug: DSB2455 — PARP1 selective inhibitor

Primary Outcomes

• Number of patients demonstrating dose limiting toxicities and SAEs (Through study completion, an average of 1 year)
• Number of patients exhibiting reduction in tumor size. (Through study completion, an average of 1 year)

About This Study

To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

Design

Interventions / Regimen

• Other: Therapeutic Education and Nursing Support Program for Supportive Care — In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy. A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.

Primary Outcomes

• To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy. (For a year)

About This Study

This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.

Design

Interventions / Regimen

• Procedure: Leukapheresis — Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample. One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.
• Biological: Dendritic Cell (DC) Vaccine — The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence. 3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.

Primary Outcomes

• Percentage of patients enrolled who successfully undergo at least one vaccination. (Up to 3 Years)

About This Study

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Design

Interventions / Regimen

• Drug: BGB-43395 — Planned doses administered orally.
• Drug: Fulvestrant — Standard dose administered via intramuscular injection.
• Drug: Letrozole — Standard dose administered orally as a tablet.
• Drug: Elacestrant — Standard dose administered orally as a tablet.
• Drug: Anti-Diarrheal Agent — Administered orally as a tablet.

Primary Outcomes

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to approximately 60 months)
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 (Up to approximately 60 months)
• Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 (Up to approximately 60 months)
• Phase 1b: Objective Response Rate (ORR) (Up to approximately 60 months)

About This Study

This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.

Design

Interventions / Regimen

• Drug: Memantine — memantine capsule
• Drug: Placebo medication — placebo capsule
• Other: Exercise Intervention — Exercise Intervention participants will concurrently engage in remotely delivered Get Real \& Heel, 3d/week. Intensity for aerobic and strength-training components will progress as tolerated under the direction of a trained exercise physiologist.
• Other: Exercise Control — Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Primary Outcomes

• Rates of recruitment (Baseline)
• Rates of retention (Up to a year)
• Rates of adherence (Up to a year)
• The acceptability of memantine + Get Real and Heel (MEM+EX) (Up to 6 months)

About This Study

The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.

Design

Interventions / Regimen

• Drug: Fulvestrant — Fulvestrant will be administered intramuscularly into the buttocks in combination with one of the other interventions as outlined above.
• Drug: Neratinib — Neratinib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
• Drug: Alpelisib — Alpelisib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
• Drug: Everolimus — Everolimus will be administered orally in tablet form once daily in combination with fulvestrant administration as outlined above.
• Drug: Abemaciclib — Abemaciclib will be administered orally in tablet form twice daily in combination with fulvestrant administration as outlined above.

Primary Outcomes

• Rate of clinical benefit within each arm in patients previously treated with a CDK4/6 inhibitor. (6 - 12 months)

About This Study

The goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast cancer. The main questions it aims to answer are: * can this dietary supplementation affect the nutritional status of breast cancer patients? * can this dietary supplementation have any beneficial effect on chemotoxicity? Participants will be asked to undergo nutritional counseling and to take the study product every day for 12 weeks. Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.

Design

Interventions / Regimen

• Dietary Supplement: FSMP — Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy
• Other: Nutritional counseling — Participant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled

Primary Outcomes

• Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity (0, 6, 12 weeks)

About This Study

This project utilizes LRRC15-specific targeted PET radiotracers to perform PET/MR or PET/CT imaging on healthy volunteers and patients with clinically suspected or confirmed malignancies characterized by high LRRC15 expression-including pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study aims to achieve the following objectives: For patients with malignant tumors: To diagnose and stage the disease. By comparing the imaging results against the gold standard of histopathological diagnosis, the study aims to evaluate diagnostic efficacy, ascertain the presence or absence of lesions, and characterize their anatomical location and nature. Furthermore, through comparison with \[¹⁸F\]FDG PET or \[⁶⁸Ga\]Ga-FAPI PET, the study seeks to achieve accurate disease staging, assess tumor burden, and facilitate therapeutic decision-making. For healthy volunteers: To conduct pharmacokinetic analyses to determine the in vivo biodistribution and metabolic patterns of the radiotracer, as well as to evaluate its safety profile.

Design

Interventions / Regimen

• Diagnostic Test: Specific PET imaging agents targeting LRRC15 — This project utilizes LRRC15-specific targeted PET radiotracers to perform PET/MR or PET/CT imaging on healthy volunteers and patients with clinically suspected or confirmed malignancies characterized by high LRRC15 expression-including pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma.

Primary Outcomes

• Visual and standardized uptake values assessment of lesions and biodistribution (1 year)

About This Study

The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.

Design

Interventions / Regimen

• Behavioral: Community Service Navigation — Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.
• Other: Usual Care — Standard referral to community resources.

Primary Outcomes

• Change in Social Needs (up to 18 months after baseline assessment)
• Episode Completion (EC). (up to 18 months after baseline assessment)