Trial comparing treatments for HR+/HER2- Breast Cancer
Official title BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
ClinicalTrials.gov ID: NCT07492641
What this study is testing
What is BGB-43395?
An investigational oral medicine being studied for advanced or metastatic hormone receptor positive, HER2-negative breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how well BGB-43395 plus letrozole works and how safe it is against a CDK4/6 inhibitor plus letrozole in patients with advanced or metastatic hormone‑receptor positive, HER2‑negative breast cancer.
- Who it's for
- It is looking for adults with advanced or metastatic HR+/HER2- breast cancer who have not received any systemic treatment for their advanced disease.
- What's involved
- Participants will receive either BGB-43395 with letrozole or a CDK4/6 inhibitor chosen by the investigator with letrozole, and will have regular visits and tests to monitor response and side effects.
- Time commitment
- The trial lasts until disease progression or unacceptable side effects, with scheduled visits and tests throughout the treatment period.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of...
- Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Adequate organ function.
You likely can't join if
- Participants who have received prior systemic treatment in the advanced or metastatic setting.
- Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting...
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Bullhead City, Arizona, United States
- Chandler, Arizona, United States
- Goodyear, Arizona, United States
- Hot Springs, Arkansas, United States
- Duarte, California, United States
- Fountain Valley, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- San Marcos, California, United States
- Santa Monica, California, United States
- West Hills, California, United States
- Lone Tree, Colorado, United States
- Danbury, Connecticut, United States
- Coral Springs, Florida, United States
- Orange City, Florida, United States
- Palm Bay, Florida, United States
- Plantation, Florida, United States
+ 203 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Bullhead City, Arizona, United States; Chandler, Arizona, United States; Goodyear, Arizona, United States and 217 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.