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
Public ClinicalTrials.gov record NCT07492641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Study identification
- NCT ID
- NCT07492641
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BeOne Medicines
- Industry
- Enrollment
- 1,056 participants
Conditions and interventions
Conditions
Interventions
- BGB-43395 Drug
- Letrozole Drug
- Abemaciclib Drug
- Palbociclib Drug
- Ribociclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 21, 2026
- Primary completion
- Mar 31, 2029
- Completion
- Aug 6, 2037
- Last update posted
- Jul 9, 2026
2026 – 2037
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology Princeton | Birmingham | Alabama | 35211 | Recruiting |
| Alaska Oncology and Hematology, Llc | Anchorage | Alaska | 99508-2974 | Recruiting |
| Ironwood Cancer and Research Centers Chandler Ii | Chandler | Arizona | 85224-5665 | Recruiting |
| Helios Clinical Research the Oncology Institute Fountain Valley | Fountain Valley | California | 92708 | Recruiting |
| Brcr Coral Springs | Coral Springs | Florida | 33065 | Recruiting |
| Florida Clinical Trials Group Plantation | Plantation | Florida | 33322 | Recruiting |
| Florida Clinical Trials Group Tamarac | Tamarac | Florida | 33321 | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | 60521-0509 | Recruiting |
| Cancer Care Specialists For Illinois | O'Fallon | Illinois | 62269 | Recruiting |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | Recruiting |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | 42303 | Recruiting |
| Cancer Partners of Nebraska April Sampson Cancer Center | Lincoln | Nebraska | 68516 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130-2042 | Recruiting |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | 08816-4096 | Recruiting |
| Summit Medical Group | Florham Park | New Jersey | 07932-1049 | Recruiting |
| Pardee Cancer Center | Hendersonville | North Carolina | 28739 | Recruiting |
| Carolina Cancer Research Center | Wilson | North Carolina | 27896 | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | 44718-2566 | Recruiting |
| Dayton Physicians Network | Dayton | Ohio | 45409 | Recruiting |
| McGlinn Cancer Institute | West Reading | Pennsylvania | 19611-2143 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07492641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07492641 live on ClinicalTrials.gov.