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| Sponsored by: |
Institute of Cancer Research - London |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033683 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: CMF regimen Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.
Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.
Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years.
Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No locally advanced tumors at diagnosis, indicated by any of the following:
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:
Other:
Contacts and Locations
Show 69 Study Locations| Study Chair: | Jane Banerji | Institute of Cancer Research, United Kingdom |
More Information
| Study ID Numbers: | CDR0000069311, ICR-TACT, EU-20109 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033683 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Antimetabolites Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Hormones Vitamin B9 Docetaxel Anti-Bacterial Agents Estrogen Receptor Modulators Methotrexate Alkylating Agents |
Breast Diseases Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Citric Acid Adjuvants, Immunologic Breast Neoplasms Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Tamoxifen Epirubicin Folic Acid Fluorouracil |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Reproductive Control Agents Cyclophosphamide Selective Estrogen Receptor Modulators Antibiotics, Antineoplastic Docetaxel Estrogen Receptor Modulators |
Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Breast Diseases Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |