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

NCT05933395 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-01-20

No results posted yet for this study

Summary

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

Interventions

DRUG

Fulvestrant

Fulvestrant will be administered intramuscularly into the buttocks in combination with one of the other interventions as outlined above.

DRUG

Neratinib

Neratinib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.

DRUG

Alpelisib

Alpelisib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.

DRUG

Everolimus

Everolimus will be administered orally in tablet form once daily in combination with fulvestrant administration as outlined above.

DRUG

Abemaciclib

Abemaciclib will be administered orally in tablet form twice daily in combination with fulvestrant administration as outlined above.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Mary Chamberlin, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2030-10-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933395 on ClinicalTrials.gov