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Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

NCT00002528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2013-04-04

No results posted yet for this study

Summary

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

Conditions

Interventions

DRUG

tamoxifen citrate

20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.

PROCEDURE

conventional surgery

Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).

RADIATION

radiation therapy

No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.

PROCEDURE

Axillary clearance

Axillary node dissection.

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Diana Crivellari, MD · Centro di Riferimento Oncologico - Aviano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-05-31
Primary Completion
2002-12-31
Completion
2010-08-31

Countries

  • Australia
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Slovenia
  • South Africa
  • Sweden
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002528 on ClinicalTrials.gov