Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

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

Trial Details

NCT ID
NCT04553770
Phase
PHASE2
Sponsor
Jonsson Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Anastrozole
  • Therapeutic Conventional Surgery
  • Trastuzumab Deruxtecan
Locations (sample)
  • Fullerton, California, United States|33.87029,-117.92534
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368
  • Torrance, California, United States|33.83585,-118.34063
  • Whittier, California, United States|33.97918,-118.03284

Key Eligibility 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 c…
  • Participants with clinically involved lymph nodes should not have radiological evidence of distant disease per standard of care staging prior to pa…
  • In the United States
  • Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central testing results not required for enroll…

For full eligibility, visit ClinicalTrials.gov.

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