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NCT01275677 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
A Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 3,270
- Enrollment target
- 20
- Study locations
NCT01275677: Completed Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT01275677 is a Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3,270 participants, above the 178-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (1737% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01275677, a Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,270 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
Primary Outcome
Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Doxorubicin
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
Study Locations (20)
Alaska
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
Alabama
- Northeast Alabama Regional Medical Center - Anniston
- Providence Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- NEA Baptist Memorial Hospital - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- Arizona Oncology Associates-Biltmore Cancer Center - Phoenix
- Virginia G Piper Cancer Care-Del Camino - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,270 participants |
| Start Date | 2011-02-08 |
| Est. Completion | 2025-06-02 |
| Phase | Phase 3 |
What the finished NCT01275677 record still lists
NCT01275677 is an interventional study that assigns participants to a tested intervention. Its 3,270 participants enrollment target places it among the larger protocols in the corpus, above the 178-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (1737% higher).
The record links to 9 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01275677 names 20 study sites across 5 states, led by Alaska, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01275677 about?
NCT01275677 is a clinical study titled "Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer". This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stoppi...
What is the current status of trial NCT01275677?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,270 participants. The study started on 2011-02-08. Estimated completion is 2025-06-02.
What conditions does trial NCT01275677 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIIC Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIB Breast Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT01275677?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01275677?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01275677 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 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 NCT01275677's enrollment target sits among peer trials
3,270 1st of 29 higher than 29 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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