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Metastatic Breast Cancer clinical trials

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NCT ID: NCT04720664 Terminated - Breast Cancer Clinical Trials

Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer

OASIS
Start date: September 22, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.

NCT ID: NCT04708860 Active, not recruiting - Breast Cancer Clinical Trials

Feasibility of Fasting & Exercise in Pts With HR+ MBC

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

NCT ID: NCT04703920 Recruiting - Clinical trials for Metastatic Breast Cancer

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

Start date: March 4, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1 dose-escalation trial is to determine the safety, tolerability and recommended phase 2 dose of talazoparib in combination with belinostat in subjects with Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer.

NCT ID: NCT04699630 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

Start date: May 3, 2021
Phase: Phase 2
Study type: Interventional

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

NCT ID: NCT04683679 Recruiting - Breast Cancer Clinical Trials

A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).

NCT ID: NCT04673019 Completed - Clinical trials for Metastatic Breast Cancer

Nurse AMIE for Echo Show: Randomized Control Trial

Start date: February 2, 2021
Phase: N/A
Study type: Interventional

The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.

NCT ID: NCT04671615 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

Start date: December 6, 2020
Phase:
Study type: Observational

The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy. This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body. Patients are followed for around 3.5 years.

NCT ID: NCT04669587 Recruiting - Clinical trials for Metastatic Breast Cancer

ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)

ENZENO
Start date: July 26, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy. Fulvestrant, the approved SERD as monotherapy or in combination with CDK4/6 inhibitors, showed superior clinical benefit compared to other endocrine therapies. Fulvestrant exhibits differential mechanism of action from other endocrine therapy, such as tamoxifen, aromatase inhibitors, which indicates that direct blockage of ER might derive better clinical activity. However, due to its route of administration by intramuscular injection, the clinical application is limited, especially with long term use. In addition, a higher dose of fulvestrant at 500 mg showed better overall survival than the lower dose at 250 mg, suggesting that more profound ER pathway modulation could derive better clinical benefit. Therefore, a SERD with improved oral bioavailability and good safety profile which enables its overdose is anticipated to achieve a more satisfactory clinical outcome with better compliance of clinical use. Preclinical data indicates that ZB716 is a novel orally bioavailable, selective ERα degrader with full ER antagonism that demonstrates superior properties than Fulvestrant. Thus, it has a potential to be effective therapy for patients with ER-positive breast cancer. This is the first time ZB716 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when ZB716 is administered orally as monotherapy and in combination with palbociclib to subjects with ER-positive, HER2 negative advanced breast cancer. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The PD effect of ZB716 on the select biomarkers for cytochrome P450 (CYP)3A4 induction (4β hydroxycholesterol) and expression of ER, PgR, and Ki67 will also be investigated. The effect of ZB716 on antitumor activity as measured by objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and PFS rate will also be investigated. The study will also investigate the effects of food on the PK of ZB716 monotherapy.

NCT ID: NCT04660435 Recruiting - Clinical trials for Metastatic Breast Cancer

To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer

TIRESIAS
Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice. Blood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.

NCT ID: NCT04639986 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

Start date: November 23, 2020
Phase: Phase 3
Study type: Interventional

The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.