A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting
Jonsson Comprehensive Cancer Center
Summary
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.
Description
PRIMARY OBJECTIVE: I. To identify treatment arm with strongest signal of efficacy, based on pathologic complete response (pCR) rate, between two neoadjuvant systemic therapy regimens in participants with early stage, HER2 low, hormone receptor positive (HR+) breast cancer. SECONDARY OBJECTIVES: I. To assess the safety profile of the two novel neoadjuvant experimental arms. II. To assess the molecular changes in tumor biomarkers including Ki67 after 1 cycle of targeted therapy. III. Pathological Assessment According to Residual Cancer Burden (RCB) Index at surgery. IV. To investigate poten…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Previously untreated operable invasive carcinoma of the breast greater than 2.0 cm (cT2) in size based on physical exam or imaging. Patients with clinical node negative disease or clinical node (cN1/cN2) positive are allowed provided they are deemed to have operable disease at study entry * Participants with clinically involved lymph nodes should not have radiological evidence of distant disease per standard of care staging prior to patient informed consent form (PICF) signature * In the United States * Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+…
Interventions
- DrugAnastrozole
Given PO
- ProcedureTherapeutic Conventional Surgery
Undergo surgery
- BiologicalTrastuzumab Deruxtecan
Given IV
Locations (9)
- St. Joseph Heritage HealthcareFullerton, California
- Cancer Blood and Specialty ClinicLos Alamitos, California
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California
- Torrance Memorial Physician Network / Cancer CareTorrance, California
- PIH HealthWhittier, California
- Orlando Health, Inc. d/b/a Orlando Health UF Health CenterOrlando, Florida