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NCT04647916 · ClinicalTrials.gov registry record · Phase 2
Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 20
- Study locations
NCT04647916: Active Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by SWOG Cancer Research Network.
NCT04647916 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 44 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04647916, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.
Primary Outcome
ORR will be evaluated using use a Simon two-stage minimax design.
Conditions Studied
Interventions
- BIOLOGICAL Sacituzumab Govitecan
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What the registry record for NCT04647916 still lists
NCT04647916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (73% lower).
The record links to 5 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which Sacituzumab Govitecan is the first listed.
NCT04647916 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04647916 about?
NCT04647916 is a clinical study titled "Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases". This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a...
What is the current status of trial NCT04647916?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2021-06-08. Estimated completion is 2028-12.
What conditions does trial NCT04647916 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Prognostic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT04647916?
The interventions under investigation include: Sacituzumab Govitecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT04647916?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04647916 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04647916's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 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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