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

Breast Cancer Clinical Trial

Official title:

QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002720
• Other study ID #: CDR0000064573
• Secondary ID: CNR-9502EU-95020
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: December 1995
• Est. completion date: December 2012

Study information

• Verified date: August 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• tamoxifen citrate

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milano (Milan)

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy,