Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00003577 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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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 may kill more tumor cells. It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: CMF regimen Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate Procedure: adjuvant therapy Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
- Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin.
- Compare the quality of life in a subgroup of these patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses.
- Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses.
Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment.
Patients are followed annually for 10 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2000 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy |
| Study Start Date : | March 1996 |
| Actual Study Completion Date : | September 2008 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histological confirmation of invasive, early stage breast cancer
- Prior complete excision of tumor required (wide local excision or mastectomy)
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Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Sex:
- Female
Menopausal status:
- Pre-, peri-, or post-menopausal
Performance status:
- Not specified
Hematopoietic:
- Adequate bone marrow function
Hepatic:
- Adequate hepatic function
Renal:
- Adequate renal function
Other:
- No prior cancer except for basal cell carcinoma or carcinoma in situ
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Concurrent hormone therapy allowed
Radiotherapy:
- No prior radiotherapy
- Concurrent radiotherapy allowed
Surgery:
- See Disease Characteristics
- No more than 6 weeks since prior surgery to the breast
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003577
| United Kingdom | |
| University of Cambridge | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Study Chair: | Helena Earl, MBBS, PhD, FRCP | Cambridge University Hospitals NHS Foundation Trust |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00003577 |
| Other Study ID Numbers: |
CDR0000066644 CRC-TU-NEAT EU-98041 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | December 19, 2013 |
| Last Verified: | February 2001 |
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stage I breast cancer stage II breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Methotrexate Epirubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites Antimetabolites, Antineoplastic Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |