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NCT02488967 · ClinicalTrials.gov registry record · Phase 3
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
A Phase 3 study of Stage IIIA Breast Cancer and HER2/Neu Negative, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 782
- Enrollment target
- 20
- Study locations
NCT02488967: Active Phase 3 study of Stage IIIA Breast Cancer and HER2/Neu Negative, sponsored by NRG Oncology.
NCT02488967 is a Phase 3 study of Stage IIIA Breast Cancer and HER2/Neu Negative that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 782 participants, above the 254-participant average among 29 other Stage IIIA Breast Cancer trials with a reported enrollment target (208% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02488967, a Phase 3 study of Stage IIIA Breast Cancer and HER2/Neu Negative, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 782 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Primary Outcome
IDFS events are local invasive recurrence after mastectomy, local invasive recurrence in the ipsilateral breast after lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause before recurrence or second primary cancer. IDFS will be compared between the two treatment arms by the stratified log-rank test. The Kaplan-Meier estimates will be calculated
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Doxorubicin Hydrochloride
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 Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Arizona Breast Cancer Specialists-Gilbert - Gilbert
- Virginia G Piper Cancer Care-Glendale - Glendale
- CTCA at Western Regional Medical Center - Goodyear
- Arizona Center for Cancer Care-Peoria - Peoria
- Arizona Oncology Associates-Biltmore Cancer Center - Phoenix
- Arizona Breast Cancer Specialists-Phoenix - Phoenix
- Arizona Oncology-Deer Valley Center - Phoenix
Alabama
- Southern Cancer Center PC-Mobile - Mobile
- Southern Cancer Center PC-Providence - Mobile
- Southern Cancer Center PC-Springhill - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 782 participants |
| Start Date | 2015-07-26 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
What the registry record for NCT02488967 still lists
NCT02488967 is an interventional study that assigns participants to a tested intervention. The registered 782 participants enrollment target is mid-sized for trials with a published cap, above the 254-participant average among 29 other Stage IIIA Breast Cancer trials with a reported enrollment target (208% higher).
The record links to 10 conditions, with Stage IIIA Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02488967 names 20 study sites across 3 states, led by Alaska, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02488967 about?
NCT02488967 is a clinical study titled "Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer". This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel...
What is the current status of trial NCT02488967?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 782 participants. The study started on 2015-07-26. Estimated completion is 2026-10-31.
What conditions does trial NCT02488967 study?
This clinical trial studies the following conditions: Stage IIIA Breast Cancer, HER2/Neu Negative, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma, Breast Adenocarcinoma.
What interventions are being tested in trial NCT02488967?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02488967?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02488967 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIIA 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 NCT02488967's enrollment target sits among peer trials
782 5th of 29 higher than 25 of 29 other Stage IIIA Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIIA 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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