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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer  Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
For Condition: stage 3B breast cancer,stage 2 breast cancer,stage 3C breast cancer,stage 3A breast cancer,inflammatory breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , Swedish Breast Cancer Group,Swiss Institute for Applied Cancer Research,Anglo Celtic Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy and surgery in treating breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of different regimens of chemotherapy plus radiation therapy with or without surgery in treating women who have locally advanced or inflammatory breast cancer.
Details: OBJECTIVES: - Compare neoadjuvant fluorouracil, epirubicin, and cyclophosphamide vs docetaxel and epirubicin followed by radiotherapy and surgery in women with locally advanced, inflammatory, or large operable breast cancer. - Compare the progression-free survival of patients treated with these regimens. - Compare the distant metastasis-free survival and survival of patients treated with these regimens. - Compare the clinical and pathological responses to these regimens in these patients. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to p53 status (negative vs positive). Patients are randomized to 1 of 2 chemotherapy treatment arms. - Patients receive 1 of 3 chemotherapy regimens comprising fluorouracil, epirubicin, and cyclophosphamide (FEC) (according to participating institution). - FEC 100: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Canadian FEC: Patients receive oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8. If oral medications are not tolerated, patients may switch to cyclophosphamide IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Tailored FEC: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over 1 hour, and cyclophosphamide IV over 1-2 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 2-15 or until blood counts recover. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive docetaxel IV over 1 hour on days 1, 22, and 43 followed by epirubicin IV over 15 minutes and docetaxel IV over 1 hour on days 64, 85, and 106 in the absence of disease progression or unacceptable toxicity. Following chemotherapy, patients may undergo loco-regional therapy comprising radiotherapy with or without breast conservation surgery or mastectomy. Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 1440 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Locally advanced or inflammatory disease - T4a-d, any N, M0 OR - Any T, N2 or N3, M0 - Large T2 or T3 breast cancer requiring tumor shrinkage prior to breast conservation surgery - No bilateral breast cancer - Frozen tumor sample available - 1 incisional biopsy OR - 2 trucut biopsies from a 14G needle - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 70 and under Sex: - Female Menopausal status: - Not specified Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.2 mg/dL - SGOT less than 60 IU/L Renal: - Creatinine less than 1.35 mg/dL Cardiovascular: - LVEF normal by echocardiography or MUGA Other: - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No serious uncontrolled medical condition - No uncontrolled psychiatric or addictive disorders - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HerveBonnefoi, , Hopital Cantonal Universitaire de Geneve
Karolinska Hospital *Recruiting*
Stockholm, , S-171 76
Sweden
Recruiting Contact Person 46-8-5177-0000
Medical University of Gdansk *Recruiting*
Gdansk, , 80-211
Poland
Recruiting Contact Person 48-58-349-2222
UniversitaetsSpital *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Contact Person 41-1-255-1111
Malmo University Hospital *Recruiting*
MALMO, , S-20502
Sweden
Recruiting Contact Person 46-40-33-1000
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-52-6911
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting Contact Person 33-147-441-501
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting Contact Person 44-1382-66-0111
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Contact Person 41-31-632-2111
Centre Paul Strauss *Recruiting*
Strasbourg, , 67085
France
Recruiting Contact Person 33-388-252-424
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3049
Portugal
Recruiting Contact Person 351-239-40-3939
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Hopital Cantonal Universitaire de Geneve *Recruiting*
Geneva, , CH-1211
Switzerland
Recruiting Contact Person 41-22-372-3311
Lund University Hospital *Recruiting*
Lund, , S-22185
Sweden
Recruiting Contact Person 46-46-177-506
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Contact Person 41-21-314-1111
Institute of Oncology, Ljubljana *Recruiting*
LJUBLJANA, , Sl-1000
Slovenia
Recruiting Contact Person 386-61-323-063
Algemeen Ziekenhuis Sint-Augustinus *Recruiting*
Wilrijk, , 2610
Belgium
Recruiting Contact Person 32-3-443-3011
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Contact Person 33-5-5633-3333
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02-781
Poland
Recruiting Contact Person 48-22-546-2169
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Contact Person 33-4-6761-3100
Sahlgrenska University Hospital *Recruiting*
Gothenburg (Goteborg), , S-413 45
Sweden
Recruiting Contact Person 46-31-342-2244
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-3-8359-8400
Orebro University Hospital *Recruiting*
OREBRO, , 70185
Sweden
Recruiting Contact Person 46-19-602-1000
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Uppsala University Hospital *Recruiting*
Uppsala, , S-75185
Sweden
Recruiting Contact Person 46-18-611-3402
Swiss Institute for Applied Cancer Research *Recruiting*
Bern, , CH-3008
Switzerland
Recruiting Barbara Muster 41-31-389-9191
Kantonsspital Basel *Recruiting*
Basel, , CH-4000
Switzerland
Recruiting Contact Person 41-61-265-2525
Kantonspital Aarau *Recruiting*
AARAU, , 5001
Switzerland
Recruiting Contact Person 41-62-838-4141
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting Contact Person 44-131-777-3500
Centre Henri Becquerel *Recruiting*
Rouen, , 76038
France
Recruiting Contact Person 33-2-3208-2222
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa *Recruiting*
Lisbon, , 1099-023 Codex
Portugal
Recruiting Contact Person 351-21-722-9800
Scottish Cancer Therapy Network *Recruiting*
Edinburgh, Scotland, EH5 3SQ
United Kingdom
Recruiting Kirsten Murray 00-44-131-551-8481
Sahlgrenska University Hospital - Molndal *Recruiting*
Molndal, , S-43180
Sweden
Recruiting Contact Person 46-31-773-1000
Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon, , F-85025
France
Recruiting Contact Person 33-2-5144-6112
Instituto Portugues de Oncologia Centro do Porto, SA *Recruiting*
Porto, , 4200
Portugal
Recruiting Contact Person 351-22-550-2011
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Contact Person 44-80-8077-7222
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting Contact Person 44-91-273-8811
CRLCC Nantes - Atlantique *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Contact Person 33-2-4067-9900
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
Centre Paul Papin *Recruiting*
Angers, , 49036
France
Recruiting Contact Person 33-2-4135-2700
Additional Information:
Study ID Numbers: CDR0000068649; EORTC-10994,ACCOG-EORTC-10994,SAKK-EORTC-10994,SBGC-EORTC-10994
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017095
Other Stage 3a Breast Cancer Studies:
1. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
2. Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
3. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
4. Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer
5. Combination Chemotherapy in Treating Women With Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Clinical Trials
Other Bern Clinical Trials
Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
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