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NCT00041119 · ClinicalTrials.gov registry record · Phase 3
Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,871
- Enrollment target
- 20
- Study locations
NCT00041119: Completed Phase 3 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
NCT00041119 is a Phase 3 study of Breast Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 3,871 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00041119, a Phase 3 study of Breast Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,871 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, 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 the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
Primary Outcome
To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG paclitaxel
- DRUG doxorubicin hydrochloride
- DRUG AC regimen
Study Locations (20)
California
- Alta Bates Summit Comprehensive Cancer Center - Berkeley
- Peninsula Medical Center - Burlingame
- East Bay Radiation Oncology Center - Castro Valley
- Valley Medical Oncology Consultants - Castro Valley - Castro Valley
- Valley Medical Oncology - Fremont
- Washington Township Hospital - Fremont
- California Cancer Center - Woodward Park Office - Fresno
- Cancer Care Associates - Fresno
- Marin Cancer Institute at Marin General Hospital - Greenbrae
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP - Marysville
- Memorial Medical Center - Modesto
Alabama
- Regional Medical Center - Anniston
- UAB Comprehensive Cancer Center - Birmingham
- Providence Cancer Center at Providence Hospital - Mobile
Alaska
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital - Fairbanks
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Arkansas
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,871 participants |
| Start Date | 2002-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00041119 record still lists
NCT00041119 is an interventional study that assigns participants to a tested intervention. Its 3,871 participants enrollment target places it among the larger protocols in the corpus, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT00041119 names 20 study sites across 5 states, led by California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT00041119 about?
NCT00041119 is a clinical study titled "Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer". This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer w...
What is the current status of trial NCT00041119?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,871 participants. The study started on 2002-05. Estimated completion is 2014-06.
What conditions does trial NCT00041119 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00041119?
The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), doxorubicin hydrochloride (DRUG), AC regimen (DRUG).
Who is sponsoring clinical trial NCT00041119?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00041119 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 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 NCT00041119's enrollment target sits among peer trials
3,871 40th of 1224 higher than 1,185 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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