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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: Recruiting Phase 2 study of Stage II Breast Cancer and Early Stage Breast Cancer, sponsored by Jonsson Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes. pCR will be calculated along with the corresponding exact 95% Clopper-Pearson confidence interval (CI).
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 |
What NCT04553770 shows while recruiting
NCT04553770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 316-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (72% lower).
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 lists 9 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Stage II Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04553770's enrollment target sits among peer trials
88 14th of 30 higher than 17 of 30 other Stage II Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage II Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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