Clinical trial · Interventional
Combination Chemotherapy in Treating Women With Breast Cancer
A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
NCT00047099CI-TRIAL-00010488completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Comparison of time to progression
Secondary outcomes (3)
- measure
- Overall survival time
- measure
- Toxicity
- measure
- Changes in quality of life over time as measured by the EORTC QLQ-C30 and BR23 questionnaires
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTJanni JW, Sommer H, Rack B, et al.: The ADEBAR trial: final toxicity analysis of a phase III study evaluating the role of docetaxel in the adjuvant therapy of breast cancer patients with extensive lymph node involvement. [Abstract] J Clin Oncol 25 (Suppl 18): A-585, 24s, 2007.
- RESULTGauger K, Bismarck FV, Heinrigs M, et al.: Phase III study evaluating the role of docetaxel in the adjuvant setting of breast cancer patients with = 4 involved lymph nodes: ADEBAR study. [Abstract] J Clin Oncol 23 (Suppl 16): A-908, 104s, 2005.
- RESULTSommer HL, Janni W, Rack B, et al.: The ADEBAR-trial: the sequencing of regional radiotherapy and chemotherapy does not influence cytostatic dose intensity. [Abstract] J Clin Oncol 23 (Suppl 16): A-744, 64s, 2005.