BGB-43395 plus letrozole vs standard CDK4/6 inhibitor with letrozole for advanced HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 study compares the combination of BGB-43395 and letrozole to the investigator’s choice of a CDK4/6 inhibitor plus letrozole in patients with newly diagnosed advanced or metastatic HR+/HER2- breast cancer. Eligible participants are adults with good performance status and adequate organ function who have not received prior systemic therapy for advanced disease. The trial evaluates efficacy and safety of the two regimens, with investigators free to select among abemaciclib, palbociclib, or ribociclib as the comparator. Primary endpoints typically include progression-free survival and safety profiles, with secondary measures such as overall response and quality of life. The study is sponsored by BeOne Medicines and is conducted at select sites in the United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alabama Oncology Princeton
  Birmingham, Alabama, United States Recruiting
• Alaska Oncology and Hematology, Llc
  Anchorage, Alaska, United States Recruiting
• Fairbanks Cancer Care Physicians Pc
  Fairbanks, Alaska, United States Recruiting
• Pioneer Research Center
  Bullhead City, Arizona, United States Recruiting
• Ironwood Cancer and Research Centers Chandler Ii
  Chandler, Arizona, United States Recruiting
• City of Hope Phoenix Cancer Center
  Goodyear, Arizona, United States Recruiting

+191 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.