Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy

Phase 2 Completed 64 enrolled Veneto Institute of Oncology IRCCS Association for Translational Research in Oncology (AS.T.R.O.) · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole.

Timeline

Start: 2014-02
Primary completion: 2018-01-12
Completion: 2018-01-12

Outcome

Met primary endpoint

paper The primary end point of the study was met, by reaching the pre-specified pCRs. PMID 30778520 ↗

Publications

Guarneri V, Dieci MV, Bisagni G, Frassoldati A, Bianchi GV, De Salvo GL, Orvieto E, Urso L, Pascual T, Pare L, Galvan P, Ambroggi M, Giorgi CA, Moretti G, Griguolo G, Vicini R, Prat A, Conte PF. De-escalated therapy for HR+/HER2+ breast cancer patients with Ki67 response after 2-week letrozole: results of the PerELISA neoadjuvant study. Ann Oncol. 2019 Jun 1;30(6):921-926. doi: 10.1093/annonc/mdz055.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous