NCT00002720

Brief Summary

RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
642

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Dec 1995

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 1995

Completed
3.9 years 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
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 20, 2013

Status Verified

August 1, 2000

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancer

Interventions

tamoxifen citrateDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven stage I, invasive breast cancer * Hormone receptor status: * Estrogen receptor positive * Progesterone receptor positive or negative PATIENT CHARACTERISTICS: Age: * 65 to 80 Sex: * Female Menopausal status: * Postmenopausal Performance status: * Not specified Life Expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No serious disease that would preclude surgery * No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Related Publications (1)

  • Martelli G, Boracchi P, Ardoino I, Lozza L, Bohm S, Vetrella G, Agresti R. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012 Dec;256(6):920-4. doi: 10.1097/SLA.0b013e31827660a8.

    PMID: 23154393DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gabriele Martelli, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

December 1, 1995

Study Completion

December 1, 2012

Last Updated

September 20, 2013

Record last verified: 2000-08

Locations

IT(1)