Clinical trial · Interventional
Combination Chemotherapy in Treating Women With Resected Breast Cancer
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
- 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 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.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| CMF regimen | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated * No clinical or radiological evidence of locoregional or metastatic disease * No locally advanced tumors at diagnosis, indicated by any of the following: * Fixed tumors * Peau d'orange skin changes * Skin ulceration * Inflammatory changes (T4 or T3b, N2 disease) * No male breast cancer * No prior invasive breast cancer or bilateral breast cancer * Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed * Must begin study chemotherapy within 8 weeks after definitive surgery * Hormone receptor status: * Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Female Menopausal status: * Not specified Performance status: * WHO 0-1 Life expectancy: * At least 2 years Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin normal * AST no greater than 1.5 times normal * Alkaline phosphatase no greater than 1.5 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious medical illness that would limit life expectancy * No psychiatric condition that would preclude informed consent * No active uncontrolled bacterial, viral, or fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * See Disease Characteristics * No prior cytotoxic chemotherapy Endocrine therapy: * No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy * No concurrent hormone replacement therapy Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since any prior unlicensed drugs * No other concurrent experimental drugs
References
Publications (2)
- RESULTHopwood P, Ellis P, Barrett-Lee P, et al.: Impact on quality of life (QL) during chemotherapy (CT) of FEC-T compared to FEC or E-CMF: results from the UK NCRI taxotere as adjuvant chemotherapy trial (TACT). [Abstract] J Clin Oncol 23 (Suppl 16): A-661, 43s, 2005.
- DERIVEDKilburn LS, Aresu M, Banerji J, Barrett-Lee P, Ellis P, Bliss JM. Can routine data be used to support cancer clinical trials? A historical baseline on which to build: retrospective linkage of data from the TACT (CRUK 01/001) breast cancer trial and the National Cancer Data Repository. Trials. 2017 Nov 23;18(1):561. doi: 10.1186/s13063-017-2308-6. PMID 29179731