A single arm phase II study of ADjuvant Endocrine therapy subcutaneous Pertuzumab and Trastuzumab fixed-dose combination for patients with anatomic stage I hormone receptor-positive HER2-positive breast cancer (ADEPT)

Brief description of study

This is a single arm open-label phase II trial of adjuvant Fixed Dose Combination (FDC) of subcutaneous (SC) trastuzumab (H) plus pertuzumab (P) and endocrine therapy without chemotherapy in patients with stage I hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. The primary endpoint is invasive disease-free survival when treated with a "de-escalated" regimen of hormonal and dual HER2-targeted therapy, with omission of a chemotherapy backbone. Eligible patients will have anatomic stage I (according to AJCC 8th edition anatomic staging table), HR+ and HER2+ breast cancer. HER2 positivity will be confirmed by central testing in all patients. Patients may be either pre- or post-menopausal. Patients must be naïve to systemic therapy for this cancer and have undergone primary breast surgery, with surgical pathology demonstrating stage I disease. After completion of primary breast surgery, patients will be registered to the trial, and receive adjuvant subcutaneous trastuzumab and pertuzumab (1 year), and hormonal therapy (at least 5 years). Patients will also receive adjuvant radiation therapy if deemed necessary per institutional practice. Patients will be followed for a total of 10 years for long-term disease outcomes. Patients will also participate in quality of life (QOL) surveys and symptom questionnaires at various time points through the course of study treatment and during follow-up. A subset of patients will participate in a single arm crossover substudy during four cycles of their overall therapy to receive two cycles of IV infusion followed by two cycles of SC FDC administration of HP, to specifically evaluate time and motion endpoints related to IV versus SC administration. Lastly, this study requires submission of tumor blocks or slides in order to perform biomarker analyses as well as blood draws for correlative analyses.


Clinical Study Identifier: s22-00647
ClinicalTrials.gov Identifier: NCT04569747
Principal Investigator: Maryann J Kwa.
Other Investigators: Yelena Novik, Nina D'Abreo, Marleen I Meyers, Ariel Karwat, Yael Simons, Amanda Marie Talmadge, Yan Fon Mei, Thomas B. Daniels, Danielle Seidman, Nancy Chan, Caitlin Elizabeth Ryan, Anastasiya Apanasyuk, Alexander A Hindenburg, Ruth Oratz, Natalie Jill Klar, Douglas K Marks.


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