Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)

ETOP IBCSG Partners Foundation

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: No axillary lymph node dissection; Procedure: Axillary lymph node dissection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00072293

CDR0000339581

IBCSG 23-01 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Full description

OBJECTIVES:

• Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
• Compare overall survival of patients treated with these regimens.
• Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
• Assess long-term surgical complications in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Enrollment: 931 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma

• Largest tumor lesion ≤ 5 cm

• Palpable or nonpalpable breast lesion

  • Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions

• Prior (preoperative) or planned (intraoperative) sentinel node biopsy required

  • At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension

• No clinical evidence of distant metastases

  • No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:

    • Skeletal pain of unknown cause
    • Elevated alkaline phosphatase
    • Bone scan showing hot spots

• No palpable axillary lymph node(s)

• No Paget's disease without invasive cancer

• Hormone receptor status:

  • Estrogen receptor and progesterone receptor known

PATIENT CHARACTERISTICS:

Age

• Any age

Sex

• Female

Menopausal status

• Any status

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• See Disease Characteristics

Renal

• Not specified

Other

• Not pregnant or nursing

• No other prior or concurrent malignancy except the following:

  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated carcinoma in situ of the cervix
  • Adequately treated in situ melanoma
  • Contralateral or ipsilateral carcinoma in situ of the breast

• No psychiatric, addictive, or other disorder that may compromise ability to give informed consent

• Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No prior systemic therapy for breast cancer
• More than 1 year since prior chemopreventive agent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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931 participants in 2 patient groups

Axillary Dissection

Active Comparator group

Description:

Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Treatment:

Procedure: Axillary lymph node dissection

No Axillary Dissection

Experimental group

Description:

Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

Treatment:

Procedure: No axillary lymph node dissection