drugset

drugset / Trial / NCT05063786

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

NCT05063786 ↗

Phase 3 Active not recruiting 27 enrolled Spanish Breast Cancer Research Group Breast International Group · collab ETOP IBCSG Partners Foundation · collab Novartis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

Timeline

Start: 2021-09-14
Primary completion: 2026-06
Completion: 2026-06

Publications

Results Perez-Fidalgo JA, Criscitiello C, Carrasco E, Regan MM, Di Leo A, Ribi K, Adam V, Bedard PL. A phase III trial of alpelisib + trastuzumab +/- fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA-mutated breast cancer. Future Oncol. 2022 Jun;18(19):2339-2349. doi: 10.2217/fon-2022-0045. Epub 2022 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	300 mg	Oral
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Comparator	Capecitabine	Small molecule	1000 mg/m2	Oral
Comparator	Capecitabine	Small molecule	1250 mg/m2	Oral
Comparator	Eribulin	Small molecule	1.23 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Trastuzumab	Monoclonal antibody	600 mg	Intravenous
Comparator	Vinorelbine	Small molecule	25 mg/m2	Oral
Comparator	Vinorelbine	Small molecule	30 mg/m2	Oral
Comparator	Vinorelbine	Small molecule	60 mg/m2	Oral

Indications