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
New Treatment for Advanced HR+/HER2- Breast Cancer: BGB-43395 vs. Standard Care
Plain English Summary
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 is a Phase 3 clinical trial sponsored by BeOne Medicines studying HR+/HER2- Breast Cancer. This study tests a new drug combination (BGB-43395 plus letrozole) against current standard treatments (a CDK4/6 inhibitor plus letrozole). It is for patients with advanced or metastatic HR+/HER2- breast cancer who have not received prior treatment for their advanced disease. Participants will be randomly assigned to receive either the new combination or the standard treatment. This involves taking oral medications. Alternative treatments include standard CDK4/6 inhibitors combined with letrozole, which are currently the go-to therapy for this patient group. The trial aims to enroll 1056 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 18 or older with confirmed HR+/HER2- breast cancer that has spread or cannot be treated with surgery. Patients must be in good general health with a performance status of 0 or 1 (able to perform daily activities). Patients who have previously received any systemic treatment for advanced or metastatic breast cancer cannot join. Patients with active brain metastases or leptomeningeal disease are excluded. This trial is studying HR+/HER2- Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
Progression-Free Survival (PFS) means the study will measure how long patients live without their cancer getting worse, which is a key indicator of treatment effectiveness. The specific primary outcome measures are: Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) (Up to approximately 4 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to find a potentially more effective treatment for patients with advanced HR+/HER2- breast cancer by exploring a new drug combination, addressing the need for improved therapies in thi As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HR+/HER2- Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant market for advanced breast cancer treatments, with the potential to offer a new option if BGB-43395 proves superior to existing CDK4/6 inhibitors, suggesting a favorab Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1056 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of BGB-43395 and the standard treatments. Understand that you will be randomly assigned to a treatment group and will not know which one you are receiving. Participation involves regular clinic visits for assessments, blood tests, and medication. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,056 participants
Interventions
- DRUG: BGB-43395 — Administered orally.
- DRUG: Letrozole — Administered orally.
- DRUG: Abemaciclib — Administered orally.
- DRUG: Palbociclib — Administered orally.
- DRUG: Ribociclib — Administered orally.
Primary Outcomes
- Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) (Up to approximately 4 years)
Secondary Outcomes
- Overall Survival (OS) (Up to approximately 11 years)
- Overall Response Rate (ORR) (Up to approximately 4 years)
- Duration of Response (DOR) (Up to approximately 4 years)
- PFS Determined by Investigator (Up to approximately 4 years)
- Clinical Benefit Rate (CBR) (Up to approximately 4 years)
Full Eligibility Criteria
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. * Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol-defined inclusion/exclusion criteria may apply.
Frequently Asked Questions
What is clinical trial NCT07492641?
NCT07492641 is a Phase 3 INTERVENTIONAL study titled "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." It is currently not yet recruiting and is sponsored by BeOne Medicines. The trial targets enrollment of 1056 participants.
What conditions does NCT07492641 study?
This trial investigates treatments for HR+/HER2- Breast Cancer. The primary condition under study is HR+/HER2- Breast Cancer.
What treatments are being tested in NCT07492641?
The interventions being studied include: BGB-43395 (DRUG), Letrozole (DRUG), Abemaciclib (DRUG), Palbociclib (DRUG), Ribociclib (DRUG). Administered orally.
What does Phase 3 mean for NCT07492641?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07492641?
This trial is currently "Not Yet Recruiting." It started on 2026-05-11. The estimated completion date is 2037-08-07.
Who is sponsoring NCT07492641?
NCT07492641 is sponsored by BeOne Medicines. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07492641?
The trial aims to enroll 1056 participants. The trial has not yet started recruiting.
How is NCT07492641 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07492641?
The primary outcome measures are: Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) (Up to approximately 4 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07492641?
The official record for NCT07492641 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07492641. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07492641 testing in simple terms?
This study tests a new drug combination (BGB-43395 plus letrozole) against current standard treatments (a CDK4/6 inhibitor plus letrozole). It is for patients with advanced or metastatic HR+/HER2- breast cancer who have not received prior treatment for their advanced disease.
Why is this trial significant?
This trial aims to find a potentially more effective treatment for patients with advanced HR+/HER2- breast cancer by exploring a new drug combination, addressing the need for improved therapies in thi As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07492641?
Common side effects may include fatigue, nausea, diarrhea, and changes in blood counts. Potential risks include allergic reactions, liver problems, and effects on heart function. Specific side effects will depend on the treatment received and individual patient response. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07492641?
Ask your doctor about the specific risks and benefits of BGB-43395 and the standard treatments. Understand that you will be randomly assigned to a treatment group and will not know which one you are receiving. Participation involves regular clinic visits for assessments, blood tests, and medication. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07492641 signal from an investment perspective?
This trial targets a significant market for advanced breast cancer treatments, with the potential to offer a new option if BGB-43395 proves superior to existing CDK4/6 inhibitors, suggesting a favorab This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to receive either the new combination or the standard treatment. This involves taking oral medications. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More HR+/HER2- Breast Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.