Study Comparing BGB-43395 and Letrozole with CDK4/6 Inhibitor and Letrozole for Advanced HR+/HER2- Breast Cancer
Sponsor: BeOne Medicines
ClinicalTrials ID:NCT07492641
This clinical trial is testing the effectiveness and safety of a new drug combination, BGB-43395 with letrozole, compared to a standard treatment option for patients with advanced hormone receptor positive, HER2-negative breast cancer who have not yet received treatment for their advanced condition.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see how well a new treatment combination of BGB-43395 and letrozole works compared to a standard treatment option that includes a CDK4/6 inhibitor and letrozole. This study is for patients with advanced or metastatic hormone receptor positive (HR+) and HER2-negative breast cancer who have not received any previous treatment for their advanced condition.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older, or the legal age of consent in the area where the study is conducted.
- Have a confirmed diagnosis of locally advanced or metastatic HR+ HER2- breast cancer.
- Must have a stable health status with an ECOG performance score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have received any previous treatment for advanced or metastatic breast cancer.
- Have been treated with any drugs targeting CDK4 or CDK2, or any other experimental cancer drugs, except for certain hormone therapies used in early-stage treatment if the cancer returned more than 12 months after the last dose.
- Have active cancer in the brain or spinal fluid that is not controlled or treated.
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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