A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Phase 2 Active not recruiting 393 enrolled Dana-Farber Cancer Institute Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) * Hormonal (endocrine) Treatment

Timeline

Start: 2021-01-11
Primary completion: 2026-03-23
Completion: 2030-09-01

Publications

Waks AG, Chen EL, Graham N, Frey AM, Almeida K, Attaya V, Ryding C, Abbass I, Fung A, Sussell J, Cortazar P, Harvey C, Leth D, Faggen M, Sinclair N, Walsh J, Tung N, Sinclair S, Lo S, Yardley D, Valero V, Meisel J, Ballinger TJ, Adams S, Carey LA, Rauch JK, Abramson VG, Williams NO, Chen WY, Leone JP, Schumer ST, Tayob N, Tolaney SM. Subcutaneous vs Intravenous Trastuzumab/Pertuzumab: A Time and Motion Substudy of a Phase II Trial of Adjuvant Trastuzumab/Pertuzumab for Stage I HER2+ Breast Cancer (ADEPT trial). JCO Oncol Pract. 2025 Mar;21(3):351-357. doi: 10.1200/OP.24.00021. Epub 2024 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	—	Oral
Subject	Exemestane	Small molecule	—	Oral
Subject	Letrozole	Other / unclassified	—	Oral
Subject	Leuprolide	Other / unclassified	—	Oral
Subject	Pertuzumab	Monoclonal antibody	—	Subcutaneous
Subject	Tamoxifen	Small molecule	—	Oral
Subject	Trastuzumab	Monoclonal antibody	—	Subcutaneous

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Summary

Timeline

Publications

Drugs

Indications