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NCT04553770 · ClinicalTrials.gov registry record · Phase 2
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
A Phase 2 study of Stage II Breast Cancer and Early Stage Breast Cancer, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 9
- Study locations
NCT04553770 is a Phase 2 study of Stage II Breast Cancer and Early Stage Breast Cancer that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 88 participants, below the 316-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (72% lower). The trial reports 9 study locations across 5 states.
The verdict
NCT04553770, a Phase 2 study of Stage II Breast Cancer and Early Stage Breast Cancer, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Anastrozole
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL Trastuzumab Deruxtecan
Study Locations (9)
California
- St. Joseph Heritage Healthcare - Fullerton
- Cancer Blood and Specialty Clinic - Los Alamitos
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Torrance Memorial Physician Network / Cancer Care - Torrance
- PIH Health - Whittier
Florida
- Orlando Health, Inc. d/b/a Orlando Health UF Health Center - Orlando
Indiana
- Ft. Wayne Medical Oncology and Hematology, Inc. - Fort Wayne
Kansas
- Cancer Center of Kansas - Wichita
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04553770
The ClinicalTrials.gov registry entry for NCT04553770 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 316-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (72% lower). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Anastrozole is the first listed.
NCT04553770 reports 9 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT04553770 about?
NCT04553770 is a clinical study titled "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 derux...
What is the current status of trial NCT04553770?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2020-10-09. Estimated completion is 2026-12-31.
What conditions does trial NCT04553770 study?
This clinical trial studies the following conditions: Stage II Breast Cancer, Early Stage Breast Cancer, Invasive Breast Cancer, Hormone Receptor-Positive Breast Carcinoma, Stage III Breast Cancer.
What interventions are being tested in trial NCT04553770?
The interventions under investigation include: Anastrozole (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Trastuzumab Deruxtecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT04553770?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04553770 being conducted?
This trial has 9 study locations across California, Florida, Indiana, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.