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Breast Neoplasms clinical trials

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NCT ID: NCT03190967 Terminated - Breast Cancer Clinical Trials

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

Start date: April 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors. Researchers want to see if combining it with the drug trastuzumab emtansine (T-DMI) prevents the formation of new metastases in the brain. Objective: To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain. Eligibility: Adults at least 18 years old with a human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to the brain and was recently treated with stereotactic radiation or surgery. Design: Participants will be screened with - Medical history - Physical exam - Heart tests - A scan (computed tomography (CT) that makes a picture of the body using a small amount of radiation - A scan (magnetic resonance imaging (MRI) that uses a magnetic field to make an image of the brain - Blood tests. - Pregnancy test. The study will be done in 3-week cycles. All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted in an arm vein. Some participants will also take Temozolomide capsules by mouth every day. Participants will keep a medication diary. During the study, participants will also: - Repeat most of the screening tests. - Answer questions about their general well-being and functioning. Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal canal low in the back and cerebrospinal fluid is collected. This will be done with local anesthesia and with the help of images. Participants will be asked to provide tumor samples when available. Participants will have a follow-up visit about 1 month after stopping the study drug. They will be contacted by telephone or email every 3 months after that.

NCT ID: NCT03186937 Terminated - Breast Cancer Clinical Trials

A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer

Start date: August 10, 2017
Phase: Phase 2
Study type: Interventional

Given preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.

NCT ID: NCT03185169 Terminated - Clinical trials for Breast Cancer Female

GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

GSM
Start date: November 18, 2016
Phase: Early Phase 1
Study type: Interventional

The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.

NCT ID: NCT03184558 Terminated - Clinical trials for Triple Negative Breast Cancer

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The primary objective is objective response rate.

NCT ID: NCT03147040 Terminated - Breast Cancer Clinical Trials

AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

GELATO
Start date: November 2, 2017
Phase: Phase 2
Study type: Interventional

This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC

NCT ID: NCT03143894 Terminated - Breast Cancer Clinical Trials

Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation

Start date: April 21, 2017
Phase: N/A
Study type: Interventional

This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.

NCT ID: NCT03137693 Terminated - Breast Cancer Clinical Trials

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

Start date: November 29, 2017
Phase: N/A
Study type: Interventional

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

NCT ID: NCT03131011 Terminated - Clinical trials for Breast Cancer Female

Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos

SPOT
Start date: September 10, 2017
Phase: N/A
Study type: Interventional

A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.

NCT ID: NCT03130439 Terminated - Breast Cancer Clinical Trials

Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Start date: May 26, 2017
Phase: Phase 2
Study type: Interventional

This research study is studying a drug called Abemaciclib as a possible treatment for have metastatic triple-negative type of breast cancer.

NCT ID: NCT03128619 Terminated - Clinical trials for Stage IV Breast Cancer

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Start date: August 2, 2017
Phase: Phase 1
Study type: Interventional

This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.