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NCT00881361 · ClinicalTrials.gov registry record · Phase 2
Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 756
- Enrollment target
- 20
- Study locations
NCT00881361: Completed Phase 2 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
NCT00881361 is a Phase 2 study of Breast Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 756 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00881361, a Phase 2 study of Breast Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 756 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.
Primary Outcome
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALN
Conditions Studied
Interventions
- PROCEDURE therapeutic conventional surgery
- DRUG systemic chemotherapy
- PROCEDURE axillary lymph node dissection
- PROCEDURE neoadjuvant therapy
- PROCEDURE sentinel lymph node biopsy
Study Locations (20)
California
- East Bay Radiation Oncology Center - Castro Valley
- Valley Medical Oncology Consultants - Castro Valley - Castro Valley
- Cancer Care Center at John Muir Health - Concord Campus - Concord
- City of Hope Comprehensive Cancer Center - Duarte
- Valley Medical Oncology - Fremont
- Todd Cancer Institute at Long Beach Memorial Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- Community Hospital of the Monterey Peninsula Comprehensive Cancer Center - Monterey
- Camino Medical Group - Treatment Center - Mountain View
- El Camino Hospital Cancer Center - Mountain View
- Highland General Hospital - Oakland
- Bay Area Breast Surgeons, Incorporated - Oakland
- CCOP - Bay Area Tumor Institute - Oakland
- Larry G Strieff MD Medical Corporation - Oakland
- Tom K Lee, Incorporated - Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center - Orange
Alabama
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Providence Cancer Center - Anchorage
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2009-07 |
| Est. Completion | 2023-04-15 |
| Phase | Phase 2 |
What the finished NCT00881361 record still lists
NCT00881361 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which therapeutic conventional surgery is the first listed.
NCT00881361 names 20 study sites across 4 states, led by California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT00881361 about?
NCT00881361 is a clinical study titled "Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This...
What is the current status of trial NCT00881361?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 756 participants. The study started on 2009-07. Estimated completion is 2023-04-15.
What conditions does trial NCT00881361 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00881361?
The interventions under investigation include: therapeutic conventional surgery (PROCEDURE), systemic chemotherapy (DRUG), axillary lymph node dissection (PROCEDURE), neoadjuvant therapy (PROCEDURE), sentinel lymph node biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT00881361?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00881361 being conducted?
This trial has 20 study locations across Alabama, Alaska, 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 NCT00881361's enrollment target sits among peer trials
756 149th of 1224 higher than 1,076 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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