NCT05933395

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

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-23
• Primary completion: 2030-10-01
• Completion: 2031-10-01
• First posted: 2023-07-06
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study