Clinical trial for Hormone-receptor-positive Breast Cancer
Official title BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06756932
What this study is testing
What is BGB-21447?
This is an investigational oral medicine being studied as a potential treatment for hormone-receptor-positive breast cancer. It is designed to stop a protein called Bcl-2, which helps cancer cells avoid dying.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a new medicine called BGB-21447 is safe when taken with other cancer drugs.
- Who it's for
- Adults with metastatic breast cancer that is hormone-receptor positive and HER2 negative.
- What's involved
- Participants will take BGB-21447 along with fulvestrant, and possibly another drug called BGB-43395.
- Time commitment
- The study involves regular visits to check safety and how the body handles the drugs.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer.
- Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Iowa City, Iowa, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Waratah, New South Wales, Australia
- Birtinya, Queensland, Australia
- Melbourne, Victoria, Australia
- St Albans, Victoria, Australia
- Nedlands, Western Australia, Australia
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Iowa City, Iowa, United States; Houston, Texas, United States; Seattle, Washington, United States; Waratah, New South Wales, Australia; Birtinya, Queensland, Australia; Melbourne, Victoria, Australia and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.