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Breast Neoplasms clinical trials

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NCT ID: NCT06254066 Not yet recruiting - Clinical trials for Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer

Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer

Start date: April 16, 2024
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib. To observe and evaluate the efficacy and safety of Adebrelimab combined with fluzoparib in the treatment of HRD-positive HR +/HER2-advanced breast cancer

NCT ID: NCT06253195 Recruiting - Breast Cancer Clinical Trials

BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.

NCT ID: NCT06253182 Recruiting - Breast Cancer Clinical Trials

Psychosexual Educational Partners Program (PEPP)

PEPP
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT). The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.

NCT ID: NCT06251544 Not yet recruiting - Breast Cancer Clinical Trials

TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer

Start date: January 2025
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer. Patients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells. The body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients. Previous research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment. Investigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2. Also, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells). The HTR2 T cells are an investigational product not approved by the Food and Drug Administration.

NCT ID: NCT06251401 Recruiting - Breast Cancer Clinical Trials

Cardiac Rehabilitation for Breast Cancer Survivors

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH.

NCT ID: NCT06248918 Enrolling by invitation - Health Behavior Clinical Trials

Nurse-led Physical Activity Program Among Breast Cancer Survivors

WATSOCPAP
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer. The impact of the nurse-led physical activity program on physical activity level, health-related quality of life and cognitive factors (self regulation, outcome expectation, self efficacy, perceived social support, perceived environment) will be evaluated in the study.

NCT ID: NCT06247995 Not yet recruiting - Breast Cancer Clinical Trials

A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

Start date: May 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).

NCT ID: NCT06247449 Recruiting - Breast Cancer Clinical Trials

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis? 3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis? Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.

NCT ID: NCT06246968 Recruiting - Breast Cancer Clinical Trials

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Start date: January 29, 2024
Phase: Phase 1
Study type: Interventional

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

NCT ID: NCT06246786 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Breast/Cyclosporin A/TNBC (Triple Negative Breast Cancer)

Start date: July 2024
Phase: Early Phase 1
Study type: Interventional

This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly diagnosed triple negative breast cancer with high g-H2Ax (gamma H2AX antibodies) comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.