Triple Drug Combo for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.The names of the study drugs involved in this study are:* VS-6766* Abemaciclib* Fulvestrant
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have taken certain medications like chemotherapy, immunotherapy, or specific endocrine or biologic agents within a certain period before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is the triple drug combo for breast cancer safe for humans?
What makes the triple drug combo for breast cancer unique?
The triple drug combo for breast cancer is unique because it combines Abemaciclib, a CDK4/6 inhibitor that helps stop cancer cell growth, with Fulvestrant and VS-6766, potentially offering a more comprehensive approach to treating HR-positive, HER2-negative advanced breast cancer compared to standard endocrine therapies alone.12346
What data supports the effectiveness of the drug combination for breast cancer?
Research shows that abemaciclib, when used with other treatments like fulvestrant, significantly improves progression-free survival in patients with advanced hormone receptor-positive, HER2-negative breast cancer. This suggests that abemaciclib is effective in treating certain types of breast cancer.23567
Who Is on the Research Team?
Adrienne Waks, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HR+/HER2- metastatic or locally advanced breast cancer that worsened on CDK4/6 inhibitors. They must have had no more than two chemo treatments in the metastatic setting, be able to take oral meds, and agree to use contraception. Excluded are those who stopped abemaciclib due to toxicity, used MEK inhibitors before, or have certain infections or severe health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Dose Escalation
Participants receive VS-6766, abemaciclib, and fulvestrant to determine the maximum tolerated dose and recommended phase II dose
Phase 2 Dose Expansion
Participants receive VS-6766, abemaciclib, and fulvestrant at the recommended phase II doses to assess clinical benefit rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Fulvestrant
- VS-6766
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adrienne G. Waks
Lead Sponsor
Verastem, Inc.
Industry Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Verastem Oncology
Collaborator