Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

This study is looking for post-menopausal women with advanced estrogen receptor-positive (ER+) breast cancer that has spread (metastatic) or come back locally and can't be cured with other treatments. You must have already been treated with a CDK4/6 inhibitor (like palbociclib, ribociclib, or abemaciclib). The study aims to find out if certain combinations of drugs are effective. These combinations involve fulvestrant given with either neratinib, alpelisib, everolimus, or abemaciclib. Researchers will measure how many patients benefit from these treatments within 6 to 12 months. The study plans to enroll 135 participants.

Study design: This is an interventional study, meaning participants will receive specific treatments. The study plans to enroll 135 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome of clinical benefit will be measured at 6 to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting

PHASE2Ages 18+InterventionalDiagnostic

Dartmouth-Hitchcock Medical Center

~135 participants

Updated 2026-01-20 on ClinicalTrials.gov

What's tested:FulvestrantNeratinibAlpelisibEverolimusAbemaciclib

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Rate of clinical benefit within each arm in patients previously treated with a CDK4/6 inhibitor.

Measured over 6 - 12 months

Conditions

Advanced Breast Cancer

Where it's being run

1 sites across 1 states

New Hampshire1

Study leadership

Mary Chamberlin, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Research Nurse

[email protected]

603-650-5021

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Up to 3 lines of therapy following CDK4/6i are permissible.

Any number of prior lines of endocrine-containing therapy is permissible.

Up to 1 prior line of chemotherapy is permissible. 4. Histologic documentation of ER+ breast cancer by core needle biopsy, fine needle aspiration, incisional biopsy, or surgical biopsy of ≥1 site(s) of metastatic or locally recurrent disease performed as standard of care.

Exceptions: patients with bone-dominant metastatic disease, or non-bone metastatic disease in whom a safe and accurate biopsy of recurrent/metastatic disease cannot be readily obtained, with a history of ER+ breast cancer are eligible, and biopsy is not required, providing their primary cancer is consistent with the ER criteria described below. 5. ER+ status defined as ER staining by immunohistochemistry in ≥1% of malignant cell nuclei. 6. Tumor must be HER2-non-amplified as defined by an immunohistochemistry score of 0-1+, or with a FISH ratio \<2 if IHC is 2+ or if IHC has not been done (as per ASCO/CAP definitions). In cases of borderline or equivocal HER2 status, eligibility will be determined by the PI. 7. Genetic profiling of a tumor or plasma specimen acquired after disease progression on a CDK4/6i must have been performed in a CAP-accredited, CLIA-certified laboratory using clinically validated methods. Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1.

If not done: Profiling of a tumor (preferable) or plasma specimen will be performed as part of the study in the DHMC Pathology Laboratory. A plasma specimen may be obtained for study-specific genetic profiling to direct treatment assignment. Tumor specimens must be obtained outside of this study (e.g., by biopsy). 8. If available, archived tumor tissue must be accessible for research purposes, sufficient to make ≥10 five-micron sections; more tumor tissue is preferred. 9. Radiographic staging performed as standard of care, including specifically either PET/CT, or contrast CT (CAP) and bone scan. 10. Patient must be capable and willing to provide informed written consent for study participation.

What this trial measures

Rate of clinical benefit within each arm in patients previously treated with a CDK4/6 inhibitor.6 - 12 months
Clinical benefit rate will be measured as the proportion of participants who experience stable disease (SD) at 24 weeks, complete response, and partial response per RECIST 1.1.

Trialytics