NCT00003854|CompletedPhase 3

Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

ACOSOG-Z0010GUMC-00152CDR0000067017

Study Type

interventional

Target

4,590

Locations

3 countries

Sites

116

Timeline

RegisteredJan 2003

StartedApr 1999

CompletionJul 2011

Brief Summary

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,590

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline

Completed

Started Apr 1999

Longer than P75 for phase_3 breast-cancer

Geographic Reach

3 countries

116 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.3 years study duration

Study Start

First participant enrolled

April 1, 1999

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed

4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

7.3 years

First QC Date

November 1, 1999

Last Update Submit

July 12, 2016

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

Overall survival
Up to 10 years

Secondary Outcomes (2)

Disease-free survival
Up to 10 years
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Up to 10 years

Study Arms (1)

Surgery + radiotherapy + adjuvant therapy

EXPERIMENTAL

Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology. Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H\&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes. All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks. Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually until 10 years after surgery.

Other: immunohistochemistry staining methodProcedure: lymphangiographyProcedure: sentinel lymph node biopsyProcedure: therapeutic conventional surgeryRadiation: whole breast irradiation