Testing a new combination of drugs for advanced 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 study evaluates the safety and effectiveness of BGB-21447, a Bcl-2 inhibitor, in combination with fulvestrant, with or without BGB-43395, a CDK4 inhibitor, for adults with hormone-receptor positive and HER2-negative metastatic breast cancer. The trial aims to determine how well these drugs work together to combat cancer cells that often resist standard treatments. Participants must have previously received at least two lines of treatment for their metastatic disease. The study is designed to provide insights into new therapeutic options for patients who have limited treatment choices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
* Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.
* Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator.
* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
* Adequate organ function.
* Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant.
* Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal.

Exclusion Criteria:

* Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4.
* Known leptomeningeal disease or uncontrolled, untreated brain metastases.
* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* For Part 1B: Uncontrolled diabetes.
* History of hepatitis B or active Hepatitis C infection
* China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \> 500 IU/ml (or \> 2500 copies/ml) at screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• Md Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Fred Hutchinson Cancer Research Center
  Seattle, Washington, United States Recruiting
• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Sunshine Coast University Private Hospital
  Birtinya, Queensland, Australia Recruiting
• Peter Maccallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

Similar studies

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

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Testing Abemaciclib with Radiation Therapy for Metastatic Breast Cancer

  This study is testing different doses of the drug abemaciclib in people with metastatic breast cancer who are also getting hormone therapy and radiation to see if it helps them better manage their symptoms.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06678269

• Measuring a biomarker for breast cancer treatment effectiveness

  This study is testing if measuring a specific biomarker can help doctors understand how well hormone treatments are working for people with advanced breast cancer.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06388122

• BGB-43395 treatment for advanced breast cancer and other solid tumors

  This study is testing a new treatment called BGB-43395 for people with advanced breast cancer and other solid tumors to see if it works better alone or with other medications.

  Recruiting at 57 sites Phase 1 BeOne Medicines · Denver, Colorado and 60 other locations · NCT06120283

• Platform program for evaluating treatments in metastatic HER2-positive breast cancer

  This study is testing different new treatments for people with advanced HER2-positive breast cancer to see which ones work best before moving them to larger trials.

  Recruiting at 5 sites Phase 1/2 QuantumLeap Healthcare Collaborative · Birmingham, Alabama and 9 other locations · NCT05868226

• Combination therapy for hormone receptor-positive metastatic breast cancer

  This study is testing a new combination of three medications to see if it can help people who have just been diagnosed with advanced hormone receptor-positive breast cancer or those who have had a relapse after being cancer-free for over a year.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT05524584

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.