Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
Public ClinicalTrials.gov record NCT04553770. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04553770
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 88 participants
Conditions and interventions
Conditions
Interventions
- Anastrozole Drug
- Therapeutic Conventional Surgery Procedure
- Trastuzumab Deruxtecan Biological
Drug · Procedure · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 8, 2020
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Nov 9, 2025
2020 – 2026
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | Recruiting |
| Cancer Blood and Specialty Clinic | Los Alamitos | California | 90720 | Recruiting |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | Recruiting |
| Torrance Memorial Physician Network / Cancer Care | Torrance | California | 90602 | Recruiting |
| PIH Health | Whittier | California | 90602 | Recruiting |
| Orlando Health, Inc. d/b/a Orlando Health UF Health Center | Orlando | Florida | 32806 | Withdrawn |
| Ft. Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46804 | Withdrawn |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04553770, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04553770 live on ClinicalTrials.gov.