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Home > "S" Clinical Trials Conditions > Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer  Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): International Breast Cancer Study Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianaCrivellari, Study Chair, Centro di Riferimento Oncologico - Aviano
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Australia
Kantonsspital - St. Gallen
St. Gallen, , CH-9006
Switzerland
Groote Schuur Hospital, Cape Town
CAPE TOWN, , 7925
South Africa
Institute of Oncology, Ljubljana
Ljubljana, , Sl-1000
Slovenia
National Institute of Oncology
Budapest, , 1125
Hungary
Anti-Cancer Council of Victoria, Melbourne
Parkville, Victoria, 3050
Australia
University Hospital
Basel, , CH-4031
Switzerland
Inselspital, Bern
BERN, , CH-3010
Switzerland
Hadassah University Hospital
Jerusalem, , 91120
Israel
UniversitaetsSpital
Zurich, , CH-8091
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Spedali Civili
Brescia, , 25124
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, 6009
Australia
Ospedale Civile Rimini
Rimini, , 47900
Italy
Auckland Adventist Hospital
Auckland, , 5
New Zealand
Presidio Ospedaliero-Gorizia
Gorizia, , 34170
Italy
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Australia
Sahlgrenska University Hospital
Gothenburg (Goteborg), , S-413 45
Sweden
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, 2050
Australia
Ospedale San Eugenio
Rome, , 00144
Italy
Additional Information:
Study ID Numbers: CDR0000078383; IBCSG-10-93,EU-93013,NCI-F93-0008
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002528
Other Stage 2 Breast Cancer Studies:
1. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
2. Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer
3. Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
4. IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
5. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Clinical Trials
Other Gothenburg (Goteborg) Clinical Trials
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
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