NCT00002528

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

Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	tamoxifen citrate	20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
PROCEDURE	conventional surgery	Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
RADIATION	radiation therapy	No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.
PROCEDURE	Axillary clearance	Axillary node dissection.

Timeline

• Start date: 1993-05-01
• Primary completion: 2002-12-01
• Completion: 2010-08-01
• First posted: 2003-01-27
• Last updated: 2013-04-04

Locations

21 sites across 9 countries: Australia, Hungary, Israel, Italy, New Zealand, Slovenia, South Africa, Sweden, Switzerland