Clinical trial · Interventional
Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)
Adjuvant Treatment of Biologically Aggressive Breast Cancer (N-,N+1,3): Controlled Clinical Study
- 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, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without epirubicin hydrochloride is more effective in treating patients with breast cancer that can be removed by surgery. PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride, to see how well it works in treating women who have undergone surgery for breast cancer. (Group III was closed to new patients as of 12/7/2009.)
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (4)
- measure
- Disease-free survival
- measure
- Toxicity
- measure
- Quality of life
- measure
- Efficacy in subgroups of patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Underwent radical mastectomy, guadrantectomy, or tumorectomy with axillary node dissection within the past 4-6 weeks
* Biologically aggressive disease
* At least 10 lymph nodes removed
* Node-negative (\> 1 cm, or \> 2 cm if histology is favorable, esp. tubular carcinoma and/or prevalent intraductal component \> 50%) tumors OR node-positive (1-3) tumors, meeting the following criteria:
* High thymidine-labeling index (\> 3%)
* Poorly differentiated tumor (grade III)
* High S-phase fraction (\> 10% by flow cytometry)
* High Ki67/MIB1 expression (\< 20%)
* No bilateral breast cancer
* No T4a, inoperable T4b, T4c, or T4d disease
* Any estrogen receptor status (positive, negative, unknown)
* No distant metastases
PATIENT CHARACTERISTICS:
* Any menopause status
* WBC ≥ 3,500/mL
* ANC ≥ 1,500/mL
* Platelet count ≥ 120,000/mL
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 mg/mL
* Bilirubin ≤ 1.5 times ULN
* Not pregnant
* Geographically accessible for follow-up
* No prior breast cancer and/or other cancer except for carcinoma in situ of the cervix or basal cell skin cancer treated with radical intent
* No significant alterations in cardiovascular function
* No serious psychiatric disorders
* No impaired renal or liver function
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDFarolfi A, Scarpi E, Rocca A, Mangia A, Biglia N, Gianni L, Tienghi A, Valerio MR, Gasparini G, Amaducci L, Faedi M, Baldini E, Rubagotti A, Maltoni R, Paradiso A, Amadori D. Time to initiation of adjuvant chemotherapy in patients with rapidly proliferating early breast cancer. Eur J Cancer. 2015 Sep;51(14):1874-81. doi: 10.1016/j.ejca.2015.07.003. Epub 2015 Jul 20. PMID 26206258