Actively Recruiting
VS-6766+Abema+Fulv in Met HR+/HER- BC
Led by Adrienne G. Waks · Updated on 2026-04-30
63
Participants Needed
3
Research Sites
305 weeks
Total Duration
On this page
Sponsors
A
Adrienne G. Waks
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
VS-6766+Abema+Fulv in Met HR+/HER- BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HR+, HER2-negative metastatic or locally recurrent unresectable invasive breast cancer
- Measurable or non-measurable disease per RECIST v1.1
- Men and pre- or postmenopausal women eligible; premenopausal women and men must have ongoing monthly GNRH agonist treatment for at least 4 weeks prior to study entry
- Radiological or objective evidence of progression on any CDK4/6 inhibitor regimen in metastatic setting or relapse/progression during or within 12 months after adjuvant CDK4/6 inhibitor regimen
- Radiological or objective evidence of progression on fulvestrant in metastatic setting
- No more than two prior chemotherapy regimens in metastatic setting
- No limit on prior endocrine therapy lines
- Phase 2 participants willing to undergo pre- and on-treatment tumor biopsies unless contraindicated
- ECOG performance status less than 2
- Adequate organ and marrow function as defined in study criteria
- Recovery from prior treatment toxicities to Grade 1 or better, except alopecia and peripheral neuropathy grade 2 or less
- Age greater than 18 years
- Women of childbearing potential, postmenopausal women via GNRH agonists, and men must agree to use adequate contraception during and after study treatment
- Female participants of childbearing potential must have negative pregnancy test within 7 days before first dose
- Ability to swallow and retain oral medication
- Ability to understand and sign informed consent
You will not qualify if you...
- Active brain metastases or carcinomatous meningitis; stable, treated brain metastases allowed if meeting criteria
- Discontinued prior abemaciclib for toxicity (phase I: any dose; phase II: at or above RP2 dose level)
- Discontinued prior fulvestrant for toxicity
- Prior treatment with any MEK inhibitor
- Recent investigational agent use within 30 days or 5 half-lives
- Chemotherapy or immunotherapy within 21 days before study drug
- Endocrine or biologic agent within 14 days before study drug
- Radiation therapy completed within 14 days before registration unless recovered from acute effects
- Major surgery within 14 days before registration
- Pre-existing ocular conditions including glaucoma, retinal vein occlusion risk factors, corneal diseases
- History of rhabdomyolysis or neuromuscular disorders with elevated creatine kinase
- Uncontrolled serious illnesses including certain cardiac, pulmonary, hepatic, renal, or metabolic conditions
- History of recent second malignancy unless disease-free or low recurrence risk as specified
- Allergic reactions to study drugs or their components
- HIV positive with recent AIDS-defining infection or requiring certain antiretroviral therapies
- Active hepatitis B or C infections without appropriate management
- Recent use of strong CYP3A4 inhibitors or inducers
- Pregnant or breastfeeding women
- Inability to swallow oral medications or gastrointestinal conditions affecting absorption
- Active systemic bacterial, fungal infections, or recent severe COVID-19
- Current treatment with warfarin without appropriate anticoagulation switch
- Other serious uncontrolled medical conditions posing high risk for toxicity per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Withdrawn
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Dana Farber Cancer Institite
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Adrienne G Waks, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here