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CDK4/6 Inhibitor
Triple Drug Combo for Breast Cancer
Phase 1 & 2
Recruiting
Led By Adrienne G Waks, MD
Research Sponsored by Adrienne G. Waks
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry. If men or pre-menopausal women have not received regular GNRH agonist for at least 4 weeks prior to study entry, these patients will be excluded.
Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks up to 2 years
Awards & highlights
Study Summary
This trial studies the safety & effectiveness of 3 drugs for HR+/HER2-negative breast cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests VS-6766 combined with abemaciclib and fulvestrant's safety and effectiveness against HR+/HER2-negative breast cancer. Participants will receive these drugs to see how well they work together after other treatments failed.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk, liver function issues, diarrhea or other digestive problems. Specific side effects related to each drug may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or woman on GNRH agonist treatment for at least 4 weeks.
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My breast cancer is hormone receptor positive, HER2 negative, and cannot be surgically removed.
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I have had 2 or fewer chemotherapy treatments for cancer that has spread.
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I can do most of my daily activities without help.
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I can swallow and keep down pills.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Maximum tolerated dose (MTD)
Phase 1 Recommended Phase II Dose (RP2D)
Phase 2 Clinical benefit rate (CBR)
Secondary outcome measures
Heart rate
Overall survival (OS)
Phase I AUC(0-384) of VS-6766
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 Dose ExpansionExperimental Treatment3 Interventions
Participants will receive VS-6766 with abemaciclib and fulvestrant at the recommended phase II doses determined in the phase I portion of the study.
Group II: Phase 1 Dose EscalationExperimental Treatment3 Interventions
During 28 day/4 week study cycle, participants will receive:
VS-6766 2x weekly for 3 out of the 4 week cycle
Abemaciclib 2x daily
Fulvestrant on day 1 of each study cycle (and day 15 of cycle 1 only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VS-6766
2021
Completed Phase 1
~20
Fulvestrant
2011
Completed Phase 3
~3690
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Verastem, Inc.Industry Sponsor
39 Previous Clinical Trials
2,555 Total Patients Enrolled
Adrienne G. WaksLead Sponsor
3 Previous Clinical Trials
190 Total Patients Enrolled
2 Trials studying Breast Cancer
150 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,961 Total Patients Enrolled
63 Trials studying Breast Cancer
36,841 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are normal.I have brain metastases, but they are stable and treated.I agree to use birth control during the study.I have not had another type of cancer, or if I did, it meets certain conditions.I do not have any severe, uncontrolled health conditions.I am a man or woman on GNRH agonist treatment for at least 4 weeks.My breast cancer is hormone receptor positive, HER2 negative, and cannot be surgically removed.I have had 2 or fewer chemotherapy treatments for cancer that has spread.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.My cancer progressed after treatment with fulvestrant.I stopped taking abemaciclib due to side effects.My cancer progressed after treatment with a CDK 4/6 inhibitor.I have been treated with a MEK inhibitor before.I have had any number of hormone treatments for my cancer.I haven't had chemotherapy or immunotherapy in the last 3 weeks.I have not taken hormone or biological therapy in the last 14 days.I finished my radiation treatment less than 14 days ago.I have not had major surgery in the last 14 days.I have an active hepatitis B or C infection.I haven't had a serious infection or COVID-19 in the last 28 days.I am currently taking warfarin.Participants may have visible or invisible disease according to RECIST v1.1.I can do most of my daily activities without help.I can swallow and keep down pills.I am HIV positive with a recent AIDS-related infection or need specific HIV treatment.I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days.I have a history of muscle breakdown or muscle disorders linked to high CK levels.I do not have any pre-existing eye conditions.I stopped taking fulvestrant due to side effects.I am willing to have tumor biopsies unless deemed risky by my doctor.I am older than 18 years.I am allergic to medications similar to VS-6766, abemaciclib, or fulvestrant.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
- Group 2: Phase 2 Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment into this clinical trial still an option?
"According to clinicaltrials.gov, this medical study is not currently recruiting participants; it was first posted on March 1st 2023 and last updated November 3rd 2022. However, there are 2597 other experiments that are presently enrolling individuals into their trials."
Answered by AI
What are the primary aims of this research endeavor?
"This trial aims to evaluate the Phase 1 MTD of the medication over a period ranging from 6 months up to 3 years. Secondary metrics include Phase I AUC(0-384) of abemaciclib, Treatment Related Adverse Events per CTCAE v5.0, and Overall Response Rate (ORR) as defined by RECIST 1.1 criteria."
Answered by AI
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