Combination Chemotherapy in Treating Women With Breast Cancer
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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 remaining tumor cells following surgery. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: goserelin acetate Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer |
- Comparison of time to progression [ Designated as safety issue: No ]
- Overall survival time [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Changes in quality of life over time as measured by the EORTC QLQ-C30 and BR23 questionnaires [ Designated as safety issue: No ]
| Estimated Enrollment: | 446 |
| Study Start Date: | August 2001 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the time to progression of women with primary breast cancer treated with fluorouracil, epirubicin, and cyclophosphamide vs docetaxel, epirubicin, and cyclophosphamide.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to metastatic axillary lymph node involvement (4-9 vs 10 or more), hormone receptor status (estrogen and/or progesterone) of the primary tumor (negative vs positive), and timing of adjuvant radiotherapy (intermittently after completion of 50% of chemotherapy vs after completion of all chemotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15 minutes on days 1 and 8 and oral cyclophosphamide on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on days 1, 21, 42, and 63 and docetaxel IV over 1 hour on days 84, 105, 126, and 147 in the absence of disease progression or unacceptable toxicity.
Within 21 days after the completion of chemotherapy, patients undergo adjuvant radiotherapy 5 days a week for 5.5 weeks. Alternatively, patients may undergo radiotherapy intermittently after completion of 50% of chemotherapy.
Upon completion of chemotherapy, patients with positive hormone receptor status (estrogen and/or progesterone) receive oral tamoxifen daily for 5 years. Additionally, patients with positive hormone receptor status who are under age 40 receive goserelin subcutaneously every 4 weeks for 2 years.
Quality of life is assessed at baseline, prior to each course of chemotherapy, 4 weeks after completion of chemotherapy, 6 weeks after completion of radiotherapy, and then at 6 months after completion of chemotherapy.
Patients are followed every 3 months for 3 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 446 patients (223 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary epithelial invasive carcinoma of the breast
- T1-4, N1-2, M0
- Must have 4 metastatic axillary lymph nodes
Complete resection of the primary tumor within the past 5 weeks
- Free of invasive carcinoma with at least 10 lymph nodes removed
- No inflammatory breast cancer
- No distant metastases by chest x-ray, liver ultrasound, and whole body bone scan
Hormone receptor status:
- Estrogen and/or progesterone receptor status known
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- At least 32 weeks
Hematopoietic
- WBC at least 3,000/mm3
- Platelet count at least 100,000
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
- Albumin no greater than 1.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No cardiomyopathy with impaired ventricular function
- No New York Heart Association class III or IV heart disease
- No cardiac arrhythmias influencing LVEF and requiring medication
- No myocardial infarction within the past 6 months
- No angina pectoris within the past 6 months
- No uncontrolled arterial hypertension
Other
- No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- No known hypersensitivity to docetaxel, epirubicin, fluorouracil, cyclophosphamide, or other study medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior cytotoxic or other antineoplastic therapy
- No other concurrent cytotoxic or other antineoplastic therapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since prior investigational agents
Contacts and Locations| Germany | |
| I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen | |
| Munich, Germany, D-80337 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Study Chair: | Harald Sommer, MD | Ludwig-Maximilians - University of Munich |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00047099 History of Changes |
| Other Study ID Numbers: | CDR0000257578, LMU-ADEBAR, EU-20221 |
| Study First Received: | October 3, 2002 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Epirubicin Tamoxifen Goserelin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013