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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002720
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: August 2000
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 642
Study Start Date: December 1995
Study Completion Date: December 2012
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.
  • Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.
  • Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002720

Locations
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
Sponsors and Collaborators
European Institute of Oncology
Investigators
Study Chair: Gabriele Martelli, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00002720     History of Changes
Other Study ID Numbers: CDR0000064573, CNR-9502, EU-95020
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 29, 2014