NCT04569747

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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. .

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Pertuzumab+TRASTUZUMAB	Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose
DRUG	ADJUVANT ENDOCRINE THERAPY	Oral, daily per cycle

Timeline

• Start date: 2021-01-11
• Primary completion: 2026-03-23
• Completion: 2030-09-01
• First posted: 2020-09-30
• Last updated: 2026-04-02

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study