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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 5 of 9 sitesv11
  2. Primary and study completion dates: Sep 30, 2025 to Dec 31, 2026
    • Site contacts updated at 7 of 9 sites
    v10
  3. Site contacts updated at 7 of 9 sitesv9
  4. Site details revised at 3 of 9 sitesv8
  5. Site contacts updated at 1 of 9 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Apr 28, 2022, no change to tracked fieldsv5-v6
  2. Collaborators: 3 to 2v4
  3. Site details revised at 7 of 9 sites
    • Collaborators: 2 to 3
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2020 to Oct 9, 2020
    • Site details revised at 9 of 9 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04553770
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Translational Research in Oncology, Daiichi Sankyo Co., Ltd.
Conditions
(from sponsor)		 Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
Related terms Breast Neoplasms
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov