Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer (10-93)

ETOP IBCSG Partners Foundation

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: radiation therapy; Procedure: Axillary clearance; Drug: tamoxifen citrate; Procedure: conventional surgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00002528

NCI-F93-0008

CDR0000078383

IBCSG-10-93

EU-93013

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

• Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
• Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Enrollment: 473 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable

• No prior axillary clearance or biopsy

• Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed

• Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign

• No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy)

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 60 and over

Sex:

• Female

Menopausal status

• Postmenopausal

Performance status:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.1 mg/dL
• AST less than 60 U/L

Renal:

• Creatinine less than 1.3 mg/dL

Cardiovascular:

• Normal cardiac function
• No history of congestive heart failure

Other:

• No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
• No psychiatric or addictive disorder that would preclude protocol therapy or informed consent
• No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
• Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for breast cancer

Chemotherapy:

• No prior chemotherapy for breast cancer

Endocrine therapy:

• No prior endocrine therapy for breast cancer

Radiotherapy:

• No prior radiotherapy for breast cancer

Surgery:

• See Disease Characteristics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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473 participants in 2 patient groups

Surgery w/ axillary clearance, tamox

Experimental group

Description:

Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

Treatment:

Radiation: radiation therapy

Procedure: Axillary clearance

Procedure: conventional surgery

Drug: tamoxifen citrate

Surgery w/o axillary clearance, tamox

Experimental group

Description:

Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

Treatment:

Radiation: radiation therapy

Procedure: conventional surgery

Drug: tamoxifen citrate