Clinical trial · Interventional
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects
NCT00054587CI-TRIAL-00011437completedPhase 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 6 FEC
- description
- Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
- interventionNames
- Biological: Trastuzumab
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: Fluorouracil
- type
- EXPERIMENTAL
- label
- 6 DE
- description
- Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
- interventionNames
- Biological: Trastuzumab
- Drug: docetaxel
- Drug: Epirubicin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast * Axillary lymph node invasion (N1, N2, or N3) * No cutaneous invasion * No T4a or greater disease * No clinically or radiologically suspected metastases * No clinically or radiologically suspected contralateral lesion * No deeply adherent or inflammatory disease * Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days * No prior breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 64 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 * ALT and AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin no greater than ULN * Hepatitis B and hepatitis C negative * No hepatic dysfunction Renal * Creatinine less than 1.3 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular * ECHO normal * LVEF at least 50% Pulmonary * FEV normal * No dyspnea at rest * No supplemental oxygen dependence Other * Not pregnant * Fertile patients must use effective contraception * HIV negative * No active infection * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No contraindication to anthracycline therapy * No chronic medical or psychological condition * No geographic or social reason that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy * No other concurrent chemotherapy * No contraindication to anthracycline therapy Endocrine therapy * No prior hormonal therapy Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics Other * At least 4 weeks since prior experimental therapy
References
Publications (6)
- BACKGROUNDMancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2. PMID 22049088
- RESULTRoché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.
- RESULTSpielmann M, Roche H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16. PMID 19917839
- RESULTSpielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.
- RESULTSpielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.
- DERIVEDO'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22. PMID 26101239