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Breast Neoplasms clinical trials

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NCT ID: NCT04872608 Withdrawn - Clinical trials for Metastatic Breast Cancer

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Start date: September 9, 2021
Phase: Phase 1
Study type: Interventional

The researchers are doing this study to find out whether the study drug onapristone ER, combined with the standard treatment for your cancer (letrozole and palbociclib), is a safe treatment for people who have metastatic or unresectable ER+/PR+/HER2- breast cancer. The researchers will test different doses of the study drug to find the highest dose that causes few or mild side effects.

NCT ID: NCT04856475 Withdrawn - Breast Cancer Clinical Trials

Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer

NeraBrain
Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomised, phase II study to evaluate the efficacy of neratinib in combination with SOC systemic therapy on CNS metastasis both as for secondary prevention (cohort 1), primary treatment (cohort 2) and for the treatment of LM disease (cohort 3) in subjects with HER2 positive metastatic BC. Subjects with metastatic HER2 positive breast cancer will be eligible for the trial and will be enrolled in one of the following cohorts: Cohort 1: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy and pre-treated with local approaches at least for the previous CNS event and currently progressive but locally treated CNS metastasis. Local therapy includes: stereotactic radiosurgery (SRS) or/and WBRT or/and surgery. The study will measure the effect of the drug combination on the time to next CNS event(s). Cohort 2: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy or progressing less than 12 months after end of adjuvant therapy with a first diagnosis of brain metastases. The study will measure the objective CNS response in each subject. Cohort 3: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy with confirmed LM defined as the presence of malignant cells in the cerebrospinal fluid (CSF) or combination of typical symptoms and MRI. The study will measure the effect of the drug combination on the time to CNS progression including LM progression. As per investigator's choice, eligible subjects in all cohort will receive neratinib in combination with capecitabine or with T-DM1 or with paclitaxel or with vinorelbine as per investigator's choice. Trastuzumab can be added as per investigator's choice to those regimens except for T-DM1. At screening and during the study treatment period (every 9 weeks), brain MRI for cohort 1 and cohort 2 or contrast-enhanced neuraxis brain and spine MRI for cohort 3 and tumour assessment by thoracic and abdomino-pelvic CT scan for all cohorts should be performed. For cohort 3 only, CSF cytological assessment should also be performed. Additionally, at screening and at each cycle during the study treatment period, subjects must fill quality of life questionnaires: EORTC core questionnaire (QLQ-C30) and brain module (QLQ-BN20).

NCT ID: NCT04828044 Withdrawn - Breast Cancer Clinical Trials

Microwave Ablation of Breast Tumors

Start date: September 2012
Phase:
Study type: Observational

The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

NCT ID: NCT04826016 Withdrawn - Clinical trials for Advanced Breast Cancer

POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

POLTER
Start date: March 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter Phase Ib/II, open-label, dose-escalation study to optimize POL6326 (balixafortide) in combination with nab-paclitaxel or eribulin in patients with HER2-negative advanced breast cancer.

NCT ID: NCT04770714 Withdrawn - Breast Cancer Clinical Trials

Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).

NCT ID: NCT04762901 Withdrawn - Breast Cancer Clinical Trials

LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, two-stage, multi-arm Phase 1 study designed to evaluate the safety and preliminary efficacy of combining niraparib with four standard chemotherapy regimens used to treat TNBC.

NCT ID: NCT04756505 Withdrawn - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial

Start date: March 7, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial is to find out the best dose, possible benefits and/or side effects of NHS-IL12 given together with bintrafusp alfa and radiation therapy in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with NHS-IL12, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody avelumab and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NHS-IL12, bintrafusp alfa, and radiation therapy may kill more tumor cells.

NCT ID: NCT04741204 Withdrawn - Insulin Resistance Clinical Trials

Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer

METBC
Start date: September 2022
Phase: Phase 4
Study type: Interventional

Breast cancer is one of the most common malignancies in women globally, with ~1.4 million new cases diagnosed annually Breast cancer is one of the leading causes of cancer-related morbidity and mortality among women worldwide. While diabetes/insulin-resistance and breast cancer are distinct diseases, insulin-signaling plays a central role in both illnesses. Insulin activates key cancer processes including epithelial-mesenchymal transition (EMT), tissue inflammation, motility, and angiogenesis. There are key opportunities to impact and prevent hyperinsulinemia during breast cancer prevention, surgical assessment, and chemotherapy. Given the high prevalence of undiagnosed pre-diabetes and diabetes in the United States and worldwide, preoperative screening to identify such patients prior to surgical intervention is warranted. While it is not standard of care to test for insulin-resistance during the course of breast cancer screening and treatment, it is standard of care to screen and test high risk women for insulin-resistance as part of whole woman care. Given the important role insulin signaling plays in driving signaling pathways that promote aggressive cancer biology, more attention should be paid by cancer physicians to screening and treating insulin resistance. Several studies have reinforced a link between breast cancer risk and diabetes. Moreover, metformin significantly reduces breast cancer risk, compared to patients who are not using metformin and is independent of diabetes status. As metformin has an association with decreased breast cancer recurrence, as well as potentially improved survival, disparities in insulin resistance between black and white women with breast cancer is important to investigate. It is hypothesized that metformin decreases the development of resistance in breast cancer cells, thereby allowing current chemotherapy agents to work synergistically with metformin. Our objective is to elucidate whether or not metformin is efficacious in improving insulin resistance in black and white women with breast cancer and if racial disparities in breast cancer prognosis can be partially explained by differences in pre-diagnosis insulin resistance which are improved with metformin therapy.

NCT ID: NCT04691999 Withdrawn - Breast Cancer Clinical Trials

The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer

EFFECT-BC
Start date: December 2, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.

NCT ID: NCT04675450 Withdrawn - Breast Cancer Clinical Trials

NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy

Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

Phase 2, randomized, double-blind, Placebo-Controlled, Multiple Dose Study for the treatment of Patients with Metastatic Breast Cancer.