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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07492641
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,056 participants
Conditions and interventions
Conditions
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
- Aug 18, 2026
2026 – 2037
United States locations
- U.S. sites
- 36
- U.S. states
- 22
- U.S. cities
- 35
| 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 |
| Genesis Cancer and Blood Institute Hot Springs (Harmony Park) | Hot Springs | Arkansas | 71913 | Recruiting |
| Helios Clinical Research the Oncology Institute Fountain Valley | Fountain Valley | California | 92708 | Recruiting |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | Recruiting |
| Brcr Coral Springs | Coral Springs | Florida | 33065 | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763-8316 | Recruiting |
| Florida Clinical Trials Group Plantation | Plantation | Florida | 33322 | Recruiting |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952-7596 | 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 | OFallon | Illinois | 62269 | Recruiting |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | Recruiting |
| Mercy Medical Center | Cedar Rapids | Iowa | 52403 | Recruiting |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | 42303 | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (Mmcorc) | Saint Paul | Minnesota | 55101-2502 | Recruiting |
| Nebraska Cancer Specialists St Francis Grand Island | Grand Island | Nebraska | 68803 | Recruiting |
| Cancer Partners of Nebraska April Sampson Cancer Center | Lincoln | Nebraska | 68516 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130-2042 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Recruiting |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | 08816-4096 | Recruiting |
| Summit Medical Group | Florham Park | New Jersey | 07932-1049 | Recruiting |
| New York Cancer and Blood Specialists | Shirley | New York | 11967 | 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 |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | Recruiting |
| McGlinn Cancer Institute | West Reading | Pennsylvania | 19611-2143 | Recruiting |
| Ballad Health Cancer Center Kingsport | Kingsport | Tennessee | 37660 | Recruiting |
| Virginia Cancer Institute | Richmond | Virginia | 23229-8605 | Recruiting |
| Multicare Cancer Institute Deaconess Medical Office Building 1 | Spokane | Washington | 99204 | Recruiting |
| Multicare Cancer Institute Tacoma General Hospital | Tacoma | Washington | 98405 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
| Multicare Cancer Institute North Star Lodge | Yakima | Washington | 98902 | 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 72 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 Aug 18, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07492641 live on ClinicalTrials.gov.