OncoMatch/Clinical Trials/NCT05933395
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
Is NCT05933395 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for advanced breast cancer.
Treatment: Fulvestrant · Neratinib · Alpelisib · Everolimus · Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC ≥1% of malignant cell nuclei)
ER+ status defined as ER staining by immunohistochemistry in ≥1% of malignant cell nuclei
Required: HER2 (ERBB2) non-amplified (IHC 0-1+ or FISH ratio <2 if IHC is 2+ or not done)
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)
Allowed: HER2 (ERBB2) study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Allowed: PIK3CA study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Allowed: AKT1 study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Allowed: MTOR study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Allowed: PTEN study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Allowed: RB1 study-relevant alteration
Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1
Prior therapy
Must have received: CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib) — advanced disease
Patient must have been treated with a CDK4/6i (either palbobclib, ribociclib, or abemaciclib) alone or in combination with an endocrine agent in the advanced disease setting
Cannot have received: CDK4/6 inhibitor (abemaciclib)
Exception: exclusion applies only if abemaciclib was the most recent or current line of therapy
Treatment with abemaciclib in the most recent or current line of therapy
Cannot have received: investigational cancer therapy
Exception: within the last 3 weeks
Any investigational cancer therapy in the last 3 weeks
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dartmouth Hitchcock Medical Center · Lebanon, New Hampshire
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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