Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)
Dartmouth-Hitchcock Medical Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Post-menopausal women ≥18 years of age with metastatic ER+ breast cancer, or with locally recurrent ER+ disease not amenable to therapy for curative intent. 2. Patient must be post-menopausal per NCCN guidelines. 3. 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. * 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…
Interventions
- DrugFulvestrant
Fulvestrant will be administered intramuscularly into the buttocks in combination with one of the other interventions as outlined above.
- DrugNeratinib
Neratinib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
- DrugAlpelisib
Alpelisib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
- DrugEverolimus
Everolimus will be administered orally in tablet form once daily in combination with fulvestrant administration as outlined above.
- DrugAbemaciclib
Abemaciclib will be administered orally in tablet form twice daily in combination with fulvestrant administration as outlined above.
Location
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire