A Phase 3 interventional study of tamoxifen citrate and conventional surgery in Breast Cancer, sponsored by ETOP IBCSG Partners Foundation. Completed at 21 sites in 9 countries. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by ETOP IBCSG Partners Foundation · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 473 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →ETOP IBCSG Partners Foundation is the lead sponsor of 52 studies on the registry; 5 are open to participants now.
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DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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.
Drug: tamoxifen citrate · Procedure: conventional surgery · Radiation: radiation therapy · Procedure: Axillary clearance
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.
Drug: tamoxifen citrate · Procedure: conventional surgery · Radiation: radiation therapy
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
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.
Axillary node dissection.
Disease-free survival
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
Time frame: 17 years from randomization
Overall survival
Time from randomization to death.
Time frame: 17 years from randomization
Toxicity
Side effects of treatment, especially surgery-related events.
Time frame: 17 years from randomization
Quality of life
Quality of life will be assessed by standard International Breast Cancer Study Group instruments
Time frame: 17 years from randomization
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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ETOP IBCSG Partners Foundation