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NCT04052555 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer
A Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 14
- Study locations
NCT04052555: Active Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04052555 is a Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (85% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04052555, a Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase Ib trial studies the best dose of berzosertib when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and/or progesterone receptor positive, HER-2 negative breast cancer. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving M6620 and radiation therapy may kill tumor cells more effectively than radiation alone or shrink or stabilize breast cancer for longer than radiation therapy alone.
Primary Outcome
The maximum tolerated dose will be defined as the highest dose level with a dose-limiting toxicity rate closest to 0.25 and =\< .33.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
- DRUG Berzosertib
Study Locations (14)
Utah
- Farmington Health Center - Farmington
- University of Utah Sugarhouse Health Center - Salt Lake City
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- NYP/Weill Cornell Medical Center - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2027-02-24 |
| Phase | Phase 1 |
What the registry record for NCT04052555 still lists
NCT04052555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04052555 lists 14 locations in 11 states (Utah, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT04052555 about?
NCT04052555 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer". This phase Ib trial studies the best dose of berzosertib when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and/or progesterone receptor positive, HER-2 negative breast cancer. Berzosertib may stop the growth of tumor cells...
What is the current status of trial NCT04052555?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-09-24. Estimated completion is 2027-02-24.
What conditions does trial NCT04052555 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Triple-Negative Breast Carcinoma, HER2-Negative Breast Carcinoma, Bilateral Breast Carcinoma, Localized Breast Carcinoma.
What interventions are being tested in trial NCT04052555?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT04052555?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04052555 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Breast Carcinoma
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 NCT04052555's enrollment target sits among peer trials
42 15th of 29 higher than 14 of 29 other Recurrent Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Breast Carcinoma 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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