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

European Institute of Oncology

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: conventional surgery; Drug: tamoxifen citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00002720

EU-95020

CDR0000064573

CNR-9502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 642 estimated patients

Sex: Female

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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