Clinical Trials in Turkey / NCT07492641
Recruiting
Phase 3
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
NCT07492641 · tracked via the Priya Life Science Turkey tracker
Condition(s) studied
HR+/HER2- Breast Cancer
Investigational drug(s) / intervention(s)
BGB-43395: Administered orally.
Letrozole: Administered orally.
Abemaciclib: Administered orally.
Palbociclib: Administered orally.
Ribociclib: Administered orally.
Study summary
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
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.
Primary outcome measure(s)
- Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) — Up to approximately 4 years
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Trial sites (189)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Oncology Princeton | Birmingham | Alabama | Recruiting |
| Alaska Oncology and Hematology, Llc | Anchorage | Alaska | Recruiting |
| Fairbanks Cancer Care Physicians Pc | Fairbanks | Alaska | Recruiting |
| Pioneer Research Center | Bullhead City | Arizona | Recruiting |
| Ironwood Cancer and Research Centers Chandler Ii | Chandler | Arizona | Recruiting |
| Genesis Cancer and Blood Institute Hot Springs (Harmony Park) | Hot Springs | Arkansas | Recruiting |
| Helios Clinical Research the Oncology Institute Fountain Valley | Fountain Valley | California | Recruiting |
| California Research Institute | Los Angeles | California | Recruiting |
| Ventura County Hematology Oncology Specialists | Oxnard | California | Recruiting |
| Brcr Coral Springs | Coral Springs | Florida | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | Recruiting |
| Cancer Care Centers of Brevard Palm Bay | Palm Bay | Florida | Recruiting |
| Florida Clinical Trials Group Plantation | Plantation | Florida | Recruiting |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | Recruiting |
| The Oncology Institute of Hope and Innovation South Miami | South Miami | Florida | Recruiting |
| Florida Clinical Trials Group Tamarac | Tamarac | Florida | Recruiting |
| Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center | Tampa | Florida | Recruiting |
| University Cancer and Blood Center Athens Comprehensive Cancer Center | Athens | Georgia | Recruiting |
| Central Georgia Cancer Care Macon Office | Macon | Georgia | Recruiting |
| Hawaii Cancer Care | Honolulu | Hawaii | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | Recruiting |
| Cancer Care Specialists For Illinois | OFallon | Illinois | Recruiting |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | Recruiting |
| Hematology Oncology of Indiana | Indianapolis | Indiana | Recruiting |
| Mercy Medical Center | Cedar Rapids | Iowa | Recruiting |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Aspirus St Lukes Hospital | Duluth | Minnesota | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (Mmcorc) | Saint Paul | Minnesota | Recruiting |
| Oncology Hematology Associates | Springfield | Missouri | Recruiting |
| Nebraska Cancer Specialists St Francis Grand Island | Grand Island | Nebraska | Recruiting |
| Cancer Partners of Nebraska April Sampson Cancer Center | Lincoln | Nebraska | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | Recruiting |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | Recruiting |
| Summit Medical Group | Florham Park | New Jersey | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| Nyu Langone Health Perlmutter Cancer Center Sunset Park | Brooklyn | New York | Recruiting |
| Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island | Mineola | New York | Recruiting |
+ 149 more sites — see the full list on the official registry below.
On this site
📄 Verzenio (abemaciclib) drug profile → 📄 Ibrance (palbociclib) drug profile → 📄 Kisqali (ribociclib) drug profile →More BeOne Medicines trials in Turkey
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07492641 on ClinicalTrials.gov ↗ ← All trials in Turkey