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NCT00785291 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
A Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 799
- Enrollment target
- 20
- Study locations
NCT00785291: Completed Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative, sponsored by National Cancer Institute (NCI).
NCT00785291 is a Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 799 participants, above the 263-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00785291, a Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 799 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, 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. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.
Primary Outcome
Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- BIOLOGICAL Bevacizumab
- DRUG Ixabepilone
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mills-Peninsula Medical Center - Burlingame
- East Bay Radiation Oncology Center - Castro Valley
- Eden Hospital Medical Center - Castro Valley
- Valley Medical Oncology Consultants-Castro Valley - Castro Valley
- City of Hope Comprehensive Cancer Center - Duarte
- Bay Area Breast Surgeons Inc - Emeryville
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente-Fremont - Fremont
- Valley Medical Oncology Consultants-Fremont - Fremont
Arkansas
- Sparks Regional Medical Center - Fort Smith
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital - Jonesboro
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 799 participants |
| Start Date | 2008-10-13 |
| Est. Completion | 2017-06-15 |
| Phase | Phase 3 |
What the finished NCT00785291 record still lists
NCT00785291 is an interventional study that assigns participants to a tested intervention. The registered 799 participants enrollment target is mid-sized for trials with a published cap, above the 263-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (204% higher).
The record links to 9 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00785291 names 20 study sites across 3 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT00785291 about?
NCT00785291 is a clinical study titled "Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer". This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulatio...
What is the current status of trial NCT00785291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2008-10-13. Estimated completion is 2017-06-15.
What conditions does trial NCT00785291 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, HER2/Neu Negative, Estrogen Receptor Negative, Progesterone Receptor Negative, Stage IV Breast Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT00785291?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Bevacizumab (BIOLOGICAL), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00785291?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00785291 being conducted?
This trial has 20 study locations across 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 NCT00785291's enrollment target sits among peer trials
799 3rd of 29 higher than 27 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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