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Metastatic Breast Cancer clinical trials

View clinical trials related to Metastatic Breast Cancer.

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NCT ID: NCT06110793 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

Start date: December 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.

NCT ID: NCT06099769 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

Start date: October 18, 2023
Phase: Phase 2
Study type: Interventional

The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.

NCT ID: NCT06083038 Recruiting - Clinical trials for Metastatic Breast Cancer

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Start date: October 5, 2023
Phase:
Study type: Observational

This is a prospective, descriptive, single site, observational study in subjects receiving alpelisib for treatment of metastatic breast cancer. The purpose of the study is to characterize the impact of alpelisib on glucose control in patients with breast cancer using continuous glucose monitoring to measure glucose levels throughout the day and night. Patients will follow a hyperglycemia prevention and management regimen aimed to diminish hyperglycemia known to occur in most oncology patients starting alpelisib. All patients will wear an Abbott FreeStyle Libre 2 system to obtain continuous glucose monitor (CGM) data (glucose measured every minute for 14 days). CGM will be placed at least 10 days prior to starting alpelisib and continue for at least 3 months while taking alpelisib.

NCT ID: NCT06072612 Recruiting - Breast Cancer Clinical Trials

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

BRIA-ABC
Start date: December 5, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

NCT ID: NCT06064812 Recruiting - Clinical trials for Metastatic Breast Cancer

A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.

Start date: September 12, 2023
Phase: Phase 1
Study type: Interventional

This is a phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer The goal of this clinical trial] is to learn about in ER+/HER2- BC participant population. The main questions it aims to answer are: - Establish the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. - Explore the safety and tolerability of FWD1802 as monotherapy and in combination with Palbociclib. - Characterise Pharmacokinetics of FWD1802 as monotherapy and in combination with palbociclib. - Explore preliminary efficacy signals.

NCT ID: NCT06044623 Recruiting - Quality of Life Clinical Trials

Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

IMPORTANT
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.

NCT ID: NCT06018337 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population.

NCT ID: NCT06016738 Recruiting - Breast Cancer Clinical Trials

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

OPERA-01
Start date: November 16, 2023
Phase: Phase 3
Study type: Interventional

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

NCT ID: NCT05964504 Recruiting - Clinical trials for Metastatic Breast Cancer

Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

Start date: December 20, 2024
Phase:
Study type: Observational [Patient Registry]

This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.

NCT ID: NCT05963997 Recruiting - Breast Cancer Clinical Trials

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

SUMIT-ELA
Start date: October 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.