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
Sponsor: BeOne Medicines
ClinicalTrials ID:NCT07492641
This study evaluates the efficacy and safety of BGB-43395 with letrozole versus a CDK4/6 inhibitor with letrozole in patients with advanced HR+/HER2- breast cancer. Eligible participants are adults with confirmed advanced HR+ HER2- BC, ECOG ≤ 1, and adequate organ function. Interventions include oral administration of BGB-43395, letrozole, abemaciclib, palbociclib, or ribociclib.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- 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 signing the informed consent.
- 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.
Exclusion Criteria
- 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 agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology and Hematology, Llc | 99508-2974 | Anchorage | Alaska |
| Cancer Care Specialists For Illinois | 62269 | O'Fallon | Illinois |
| Nebraska Cancer Specialists | 68130-2042 | Omaha | Nebraska |
| Astera Cancer Care East Brunswick | 08816-4096 | East Brunswick | New Jersey |
| Gabrail Cancer Center Research | 44718-2566 | Canton | Ohio |
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