Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer (NCT04553770)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Joseph Heritage Healthcare — Fullerton, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- St. Joseph Heritage Healthcare — Fullerton, California
- Cancer Blood and Specialty Clinic — Los Alamitos, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
- Torrance Memorial Physician Network / Cancer Care — Torrance, California
- PIH Health — Whittier, California
- Orlando Health, Inc. d/b/a Orlando Health UF Health Center — Orlando, Florida
- Ft. Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana
- Cancer Center of Kansas — Wichita, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (310) 829-5471
Email: ISTTeam@mednet.ucla.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.