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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Surgery in Treating Women With Breast Cancer  Chemotherapy Plus Surgery in Treating Women With Breast Cancer
Chemotherapy Plus Surgery in Treating Women With Breast Cancer
For Condition: stage 3A breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): Istituto Nazionale per lo Studio e la Cura dei Tumori ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer.
Details: OBJECTIVES: - Evaluate whether 8 courses of primary chemotherapy before adequate surgery of breast tumor and locoregional radiotherapy plus tamoxifen for 5 years improves the disease-free and overall survival in women with operable breast carcinoma and tumor at diagnosis greater than 2 cm in diameter. - Assess whether, in the postoperative arms, the addition of paclitaxel to doxorubicin before CMF (cyclophosphamide, methotrexate, and fluorouracil) improves disease-free and overall survival in these patients. - Define the incidence of pathologic complete response (CR) induced by 8 courses of primary chemotherapy containing paclitaxel. - Assess whether a pathologic CR is an independent predictor of disease-free and overall survival. - Evaluate the effects of primary chemotherapy on the rate and quality of breast conserving surgery. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor diameter at mammography, nuclear or histological grade, and estrogen/progesterone receptor status. Patients are randomized to one of three treatment arms. - Arm I: Patients receive doxorubicin IV over 15 minutes once every 3 weeks for 4 courses. Beginning 21 days after the last administration of doxorubicin, patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1 and 8. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Arms II and III: Patients receive doxorubicin IV over 15 minutes and paclitaxel IV over 3 hours once every 3 weeks for 4 courses. Beginning 21 days after the last administration of doxorubicin and paclitaxel, patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. All patients have either mastectomy or breast conserving surgery; patients with unclear surgical margins may have second surgery (re-resection or total mastectomy) or radiotherapy. Lymph node axillary dissection is performed up to at least the second level. For patients in the 2 adjuvant arms (arms I and II), adjuvant chemotherapy starts by day 21 after surgery. For patients in the primary chemotherapy arm (arm III), surgery is performed by day 28 after the last course of chemotherapy or at resolution of all possible hematological or infective complications. At the end of the combined surgery plus chemotherapy approach (i.e., after the last course of CMF (arms I and II) or after surgery (arm III)), patients enrolled after June 30, 2000 with estrogen or progesterone receptor positive disease receive oral tamoxifen daily for 5 years. All patients who have breast conserving surgery receive postoperative irradiation within 4 weeks after completing chemotherapy and surgery (i.e., within 4 weeks from last dose of adjuvant chemotherapy (arms I and II) or from surgery (arm III)). All patients who have mastectomy and have pT4 disease must receive irradiation to the chest wall. Patients are followed at 6, 12, 18, and 24 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 450 patients per arm will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Unilateral carcinoma of the breast that has not been previously treated with standard therapies - Tumor greater than 2 cm in its maximum diameter as assessed by mammography, except: - No locally advanced disease, i.e., no tumor with direct extension to the chest wall or skin - No metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 to 70 Sex: - Female Menopausal status: - Not specified Performance status: - Karnofsky 80-100% Hematopoietic: - Granulocyte count at least 2,000/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin within upper limits of normal (ULN) - Alkaline phosphatase no greater than 1.5 times ULN - AST no greater than 1.5 times ULN - No chronic active hepatitis Renal: - Creatinine within ULN Cardiovascular: - No prior atrial or ventricular arrhythmias - No history of congestive heart failure - No myocardial infarction within the past 6 months - No uncontrolled hypertension Neurologic: - No pre-existing motor or sensory neuropathy greater than grade 1 Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No active infection - No history of second malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - No prior endocrine therapy Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery - No prior surgical biopsy of breast nodule
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GianniBonadonna, Study Chair, Istituto Nazionale per lo Studio e la Cura dei Tumori
Moscow Clinical Dispenser
Moscow, , 129128
Russian Federation
St. Elizabeth Cancer Institute Hospital
Bratislava, , SK-81250
Slovakia
Hospital General Universitari Vall d'Hebron
Barcelona, , 08035
Spain
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , 115478
Russian Federation
University of Tartu
Tartu, , 51003
Estonia
Szpital Kliniczny NR 1
Poznan, , PL-61-878
Poland
Ospedale San Bortolo
Vicenza, , 36100
Italy
Semmelweis University
Budapest, , 1082
Hungary
Regional Center of Oncology
Bydgoszcz, , 85-796
Poland
Jagiellonian University
Krakow (Cracow), , 31-826
Poland
Ospedale St. Santa Chiara
Pisa, , 56100
Italy
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Instituto Valenciano De Oncologia
Valencia, , 46009
Spain
Frauenklinik Vom Roten Kreuz
Munich, , 80637
Germany
Regional Oncology Clinic
Murmansk, , 183047
Russian Federation
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Centro di Riferimento Oncologico - Aviano
Trento, , 38100
Italy
N. A. Semashko Central Clinical Hospital
Moscow, , 129128
Russian Federation
Radiotherapy Institute
Ostrava-Poruba, , 70852
Czech Republic
Petrov Research Institute of Oncology
Saint Petersburg, , 197758
Russian Federation
Hospital Clinico Universitario de Valencia
Valencia, , 46010
Spain
Hospital Clinico Universitario - Malaga
Malaga, , 29010
Spain
Policlinico Monteluce
Perugia, , 06122
Italy
Latvian Cancer Center
Riga, , 1079
Latvia
Uzsoki Hospital
Budapest, , 1145
Hungary
Hospital de la Santa Cruz I Sant Pau
Barcelona, , 08025
Spain
Universita Degli Studi di Udine
Udine, , 33100
Italy
Additional Information:
Study ID Numbers: CDR0000065593; INT-23/96,EU-97001
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003013
Other Stage 2 Breast Cancer Studies:
1. Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
2. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer
4. Combination Chemotherapy in Treating Women With Breast Cancer
5. Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Clinical Trials
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Chemotherapy Plus Surgery in Treating Women With Breast Cancer
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