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Compares treatment options 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?
BGB-43395 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hr+/her2- 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 purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
- 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. Note: Other protocol-defined inclusion/exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Chandler, Arizona, United States
- Fountain Valley, California, United States
- Coral Springs, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Hinsdale, Illinois, United States
- O'Fallon, Illinois, United States
- Fort Wayne, Indiana, United States
- Owensboro, Kentucky, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- East Brunswick, New Jersey, United States
- Florham Park, New Jersey, United States
- Hendersonville, North Carolina, United States
- Wilson, North Carolina, United States
- Canton, Ohio, United States
- Dayton, Ohio, United States
- West Reading, Pennsylvania, United States
+ 40 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 - 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?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Chandler, Arizona, United States; Fountain Valley, California, United States; Coral Springs, Florida, United States; Plantation, Florida, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.