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Breast Neoplasms clinical trials

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NCT ID: NCT04714619 Terminated - Clinical trials for Advanced Breast Cancer

CB-103 Plus NSAI In Luminal Advanced Breast Cancer

CAILA
Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

Multicenter, single-arm, open label, phase II clinical trial with safety run-in to evaluate the safety, tolerability, pharmacokinetics and efficacy of CB-103 in combination with a non-steroidal aromatase inhibitor (NSAI), anastrozole or letrozole, in Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer patients who have achieved clinical benefit during prior NSAI-based treatment.

NCT ID: NCT04705025 Terminated - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer

BNT001
Start date: April 8, 2021
Phase: N/A
Study type: Interventional

This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.

NCT ID: NCT04691375 Terminated - Breast Cancer Clinical Trials

A Study of PY314 in Subjects With Advanced Solid Tumors

Start date: October 29, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).

NCT ID: NCT04690855 Terminated - Breast Cancer Clinical Trials

A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer

TARA
Start date: October 4, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II study designed to assess efficacy and safety of talazoparib, high dose radiation, and atezolizumab in patients with metastatic TNBC that is PD-L1 positive. A total of 23 gBRCA pathogenic variant negative patients will be enrolled. All patients will be treated with induction talazoparib of 1mg PO daily starting Day 1. Patients will then receive 8 Gy x 3 fractions to 2-4 metastatic lesions beginning Day 12,13, or 14 and given QOD. 840 mg of atezolizumab will be given intravenously (IV) on Day 15 of the 1st cycle and then on Day 1 and Day 15 of the remaining cycles. The sequence of administration is not specified on the days in which talazoparib and atezolizumab are given on the same day. Each cycle equals 28 days. Treatment will continue until progression or severe toxicity. A safety lead in of up to 6 patients will be performed. Immune-related and non-immune related adverse events will be tracked up to 12 weeks post initiation of atezolizumab, as the majority of treatment-related toxicities from talazoparib, radiation, and atezolizumab occur within this time period.

NCT ID: NCT04665921 Terminated - Clinical trials for Colorectal Neoplasms

A Study of SGN-STNV in Advanced Solid Tumors

Start date: January 18, 2021
Phase: Phase 1
Study type: Interventional

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

NCT ID: NCT04657679 Terminated - Breast Cancer Clinical Trials

Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts

LEANORA
Start date: May 20, 2021
Phase: Phase 4
Study type: Interventional

The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients. The investigators hypothesize that patients treated with ribociclib who are CYP3A5 poor metabolizers may be exposed to higher levels of ribociclib than CYP3A5 intermediate or normal metabolizers. The findings could allow clinicians to tailor treatments to maintain therapeutic doses while limiting toxicities.

NCT ID: NCT04655573 Terminated - Clinical trials for Advanced Breast Cancer

A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer

Start date: April 7, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to assess the feasibility of generating patient derived micro-organospheres (PDMO) from patients with advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.

NCT ID: NCT04639245 Terminated - Clinical trials for Metastatic Malignant Solid Neoplasm

Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer

Start date: July 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial investigates the side effects of genetically engineered cells called FH-MagIC TCR-T cells and how well they work with atezolizumab in treating patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer that has spread to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize MAGE-A1, a protein on the surface of tumor cells. These MAGE-A1-specific T cells may help the body's immune system identify and kill MAGE-A1 tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FH-MagIC TCR-T cells with atezolizumab may help treat patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer.

NCT ID: NCT04576247 Terminated - Clinical trials for Overweight and Obesity

Combined Modality Exercise and Appetite in Breast Cancer Survivors

CARE
Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).

NCT ID: NCT04562233 Terminated - Breast Cancer Clinical Trials

Breast Cancer and Resistance Exercise Program

B-REP
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The goal of the study is to test the feasibility and acceptability of a supervised, online-delivered, individualized, physical activity program in a sample of post-active treatment breast cancer survivors. The proposed intervention will use a 2-arm randomized controlled trial study design to compare a 12-week resistance-based physical activity program to an attention control (i.e., printed individualized physical activity program) group on feasibility, acceptability and changes in strength as measured by 10 repetition maximum (10RM). Both groups will wear accelerometers. The main hypothesis is that participants randomized to the intervention arm will rate the online-delivered physical activity program as feasible and acceptable compared to attention control participants. The overall rationale is that delivering a physical activity intervention online may increase uptake of the intervention, which may lead to maintained physical activity behavior and associated health benefits. The primary outcomes are feasibility as measured by participant retention and acceptability as measured by adherence to physical activity program (recorded by physical activity log). Secondary outcomes include changes in strength as measured by 10RM, objectively measured physical activity levels as measured by the accelerometer, satisfaction, physical functioning and health-related quality of life. Additionally, a select number of participants will be invited for an interview to talk about their experiences in the program, motivation and barriers to exercise. Interview description: Participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and audio recorded using the "record meeting" function. Prior to the interview, participants will consent to being audio recorded. The recording will be stored on Box (a HIPAA compliant cloud drive). A transcript of the audio will be generated using the "audio transcript" function on Rutgers Zoom and transcribed by a third party to ensure accuracy.