CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 756 enrolled
Drug / intervention
systemic chemotherapy +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00881361
NCT00881361Phase 2Completed

A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 15, 2009·Updated Apr 27, 2023

In Brief

A Phase 2 clinical trial evaluating systemic chemotherapy, axillary lymph node dissection, and 4 other interventions for Breast Cancer. Completed, enrolled 756 participants across 324 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2012
Study CompletionApr 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.2 years ago

Interventions

systemic chemotherapydrug

axillary lymph node dissectionprocedure

neoadjuvant therapyprocedure

sentinel lymph node biopsyprocedure

therapeutic conventional surgeryprocedure

ultrasound imagingprocedure