Actively Recruiting
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-01-20
135
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
CONDITIONS
Official Title
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menopausal women 18 years or older with metastatic or locally recurrent estrogen receptor-positive breast cancer not curable with therapy
- Post-menopausal status confirmed per NCCN guidelines
- Prior treatment with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alone or with endocrine therapy in advanced disease
- Up to 3 lines of therapy allowed after CDK4/6 inhibitor treatment
- Any number of prior endocrine therapy lines allowed
- Up to 1 prior chemotherapy line allowed
- Histologic proof of estrogen receptor-positive breast cancer from biopsy of at least one metastatic or locally recurrent site, with exceptions for bone-dominant or inaccessible metastases
- Estrogen receptor positivity defined as at least 1% staining of malignant cell nuclei by immunohistochemistry
- Tumor must be HER2-non-amplified by immunohistochemistry or FISH per ASCO/CAP guidelines
- Genetic profiling of tumor or plasma after progression on CDK4/6 inhibitor performed in certified laboratories, including key gene analyses
- Archived tumor tissue available for research if possible
- Radiographic staging performed with PET/CT or contrast CT and bone scan
- Willing and able to provide informed written consent
You will not qualify if you...
- Treatment with abemaciclib in the most recent or current therapy line
- Concurrent anti-cancer therapies during treatment phases, except anti-resorptive bone therapies like bisphosphonates or denosumab
- Participation in investigational cancer therapy within the last 3 weeks
- Known untreated central nervous system disease unless stable for at least 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
R
Research Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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