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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Swedish Breast Cancer Group Swiss Group for Clinical Cancer Research Anglo Celtic Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017095 |
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: This randomized phase III trial is studying three different regimens of chemotherapy given together with radiation therapy with or without surgery and comparing how well they work in treating women with locally advanced or inflammatory breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: filgrastim Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen |
Estimated Enrollment: | 1850 |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (large T2-3 vs locally advanced or inflammatory), p53 status (negative vs positive vs unknown), and participating center. Patients are randomized to 1 of 2 chemotherapy treatment arms.
Arm I: Patients receive 1 of 3 chemotherapy regimens comprising fluorouracil, epirubicin, and cyclophosphamide (FEC) (according to participating institution).
Following chemotherapy, patients may undergo loco-regional therapy comprising radiotherapy with or without breast conservation surgery or mastectomy. Patients with estrogen- and/or progesterone-receptor-positive disease also receive tamoxifen or an aromatase inhibitor for 5 years.
Patients are followed every 3 months for 1 year, every 4 months for 1.5 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,850 patients will be accrued for this study within 5.5 years.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Locally advanced or inflammatory disease
Frozen tumor sample available
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Investigator: | Herve Bonnefoi, MD | Hopital Cantonal Universitaire de Geneve |
Study Chair: | Jonas Bergh, MD, PhD | Karolinska University Hospital - Solna |
Study Chair: | Barbara Muster | Swiss Group for Clinical Cancer Research |
Study Chair: | Kirsten Murray | Scottish Cancer Therapy Network |
Study ID Numbers: | CDR0000068649, EORTC-10994, ACCOG-EORTC-10994, SAKK-EORTC-10994, SBGC-EORTC-10994, BIG-1-00 |
Study First Received: | June 6, 2001 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00017095 |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer inflammatory breast cancer |
Docetaxel Inflammatory breast cancer Skin Diseases Fluorouracil Breast Neoplasms |
Cyclophosphamide Taxane Epirubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |