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NCT02445391 · ClinicalTrials.gov registry record · Phase 3
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
A Phase 3 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 3
- Development phase
- 415
- Enrollment target
- 20
- Study locations
NCT02445391: Active Phase 3 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by ECOG-ACRIN Cancer Research Group.
NCT02445391 is a Phase 3 study of Invasive Breast Carcinoma and Stage II Breast Cancer that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 415 participants, below the 476-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445391, a Phase 3 study of Invasive Breast Carcinoma and Stage II Breast Cancer, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 415 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, 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 cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
Primary Outcome
IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Capecitabine
- DRUG Cisplatin
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
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- Mobile Infirmary Medical Center - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2015-10-20 |
| Est. Completion | 2031-03-29 |
| Phase | Phase 3 |
What the registry record for NCT02445391 still lists
NCT02445391 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, below the 476-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (13% lower).
The record links to 10 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT02445391 names 20 study sites across 5 states, led by Alaska, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02445391 about?
NCT02445391 is a clinical study titled "Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy". This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherap...
What is the current status of trial NCT02445391?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 415 participants. The study started on 2015-10-20. Estimated completion is 2031-03-29.
What conditions does trial NCT02445391 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer, Stage IIIA Breast Cancer, HER2/Neu Negative, Stage IIIB Breast Cancer.
What interventions are being tested in trial NCT02445391?
The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Cisplatin (DRUG).
Who is sponsoring clinical trial NCT02445391?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445391 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive 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 NCT02445391's enrollment target sits among peer trials
415 13th of 45 higher than 33 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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