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 — ADEPT  

Breast Cancer Clinical Trial

Official title: 20-347 NCT Number Title 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 (ADEPT)

Status Recruiting

Clinical Trial 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

Clinical Trial Description

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, physical exams, questionnaires, and follow up visits.

• Participants will receive HER2-directed treatment for 1 year and hormonal therapy for approximately 5 years.

• It is expected that about 375 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. The U.S. Food and Drug Administration (FDA) has approved trastuzumab, pertuzumab, and trastuzumab + pertuzumab subcutaneous fixed dose combination (PHESGO) as treatment for HER2 positive breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer.

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Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Hormone Receptor Positive Breast Cancer
• Invasive Carcinoma of the Breast
• Micrometastasis Breast Cancer
• Node Negative Breast Cancer

• NCT number: NCT04569747
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Adrienne Waks, MD
• Phone: 617-632-3800
• Email: awaks@partners.org
• Status: Recruiting
• Phase: Phase 2
• Start date: January 11, 2021
• Completion date: September 1, 2030