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NCT02282345 · ClinicalTrials.gov registry record · Phase 2
Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer
A Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02282345: Completed Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
NCT02282345 is a Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 484-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02282345, a Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may be especially effective in patients with BRCA mutations. It is not yet known whether adding talazoparib before standard treatment is safe in treating patients with BRCA mutated breast cancer.
Primary Outcome
Pathologic response was documented using the Residual Cancer Burden (RCB) Calculator. Residual cancer burden by ICR will be reported as a categorical variable with four classes (categories) RCB 0 (pCR) which correlates to no invasive disease in breast and lymph, I (minimal RCB), II (moderate RCB), and III (extensive RCB). Up to two fine needle aspirates (FNAs) will also be obtained at each time point for a total of up to 6 FNA's for the trial, which will be used for the patient derived xenograft
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Talazoparib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-04-16 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 2 |
What the finished NCT02282345 record still lists
NCT02282345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 484-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02282345 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02282345 about?
NCT02282345 is a clinical study titled "Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer". This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking s...
What is the current status of trial NCT02282345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2015-04-16. Estimated completion is 2022-06-07.
What conditions does trial NCT02282345 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, HER2/Neu Negative, Breast Adenocarcinoma, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation.
What interventions are being tested in trial NCT02282345?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Talazoparib (DRUG).
Who is sponsoring clinical trial NCT02282345?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02282345 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02282345's enrollment target sits among peer trials
36 41st of 45 higher than 4 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive 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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