Clinical trial · Interventional
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
NCT00055679CI-TRIAL-00010744completedPhase 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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 6 FEC
- description
- 6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
- interventionNames
- Drug: cyclophosphamide
- Drug: epirubicin hydrochloride
- Drug: fluorouracil
- type
- EXPERIMENTAL
- label
- 4 FEC
- description
- 4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
- interventionNames
- Drug: cyclophosphamide
- Drug: epirubicin hydrochloride
- Drug: fluorouracil
Primary outcomes (1)
- measure
- Efficacy, in terms of 5-year survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
* Stage I
* No clinically or radiologically suspicious metastases
* No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm
* No clinically proven positive axillary lymph nodes
* Tumor cells found on immunohistochemistry only allowed
* No clinically or radiologically contralateral suspicious lesions
* No deeply adherent disease
* No cutaneous invasion
* No inflammatory disease
* Complete surgical resection within the past 42 days
* At least 8 lymph nodes removed
* Tumor at least 1 cm with no residual disease
* Presenting with at least 1 of the following factors of a poor prognosis:
* Tumor greater than 2 cm
* Hormone receptor negative tumor
* Grade II or III
* 35 years old or under
* Hormone receptor status:
* Positive or negative
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Sex
* Female
Menopausal status
* Not specified
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* AST and ALT no greater than 1.25 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* No chronic hepatitis B
* No active hepatitis C
Renal
* Creatinine no greater than 1.25 times ULN
Pulmonary
* FEV normal
Other
* Not pregnant or nursing
* HIV negative
* No prior breast cancer or other malignancy
* No familial, social, or geographical reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* No prior anticancer hormone therapy
Radiotherapy
* No prior radiotherapy
Surgery
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDKerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain E, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roche H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11. PMID 28501763