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NCT01818063 · ClinicalTrials.gov registry record · Phase 2
Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
A Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 3
- Study locations
NCT01818063: Completed Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01818063 is a Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 9 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01818063, a Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 3
- Study locations
Study Summary
This randomized phase II trial studies how well carboplatin and combination chemotherapy with or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and combination chemotherapy are more effective with or without veliparib is more effective in treating breast cancer.
Primary Outcome
PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H\&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Veliparib
Study Locations (3)
Pennsylvania
- Thomas Jefferson University - Philadelphia
- Reading Hospital - Reading
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-04-25 |
| Est. Completion | 2018-12-10 |
| Phase | Phase 2 |
What the finished NCT01818063 record still lists
NCT01818063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 8 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01818063 reports a single indexed study location in Pennsylvania, Maryland.
Frequently Asked Questions
What is clinical trial NCT01818063 about?
NCT01818063 is a clinical study titled "Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer". This randomized phase II trial studies how well carboplatin and combination chemotherapy with or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and cyclophosphamide, work in diffe...
What is the current status of trial NCT01818063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2013-04-25. Estimated completion is 2018-12-10.
What conditions does trial NCT01818063 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, HER2-Negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer.
What interventions are being tested in trial NCT01818063?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Veliparib (DRUG).
Who is sponsoring clinical trial NCT01818063?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01818063 being conducted?
This trial has 3 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative 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 NCT01818063's enrollment target sits among peer trials
9 115th of 118 higher than 3 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative 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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