Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
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ClinicalTrials.gov Identifier: NCT00054587 |
Recruitment Status
:
Completed
First Posted
: February 6, 2003
Last Update Posted
: July 19, 2013
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: Trastuzumab Drug: Cyclophosphamide Drug: docetaxel Drug: Epirubicin Drug: Fluorouracil | Phase 3 |
OBJECTIVES:
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
- Determine survival of patients treated with these regimens.
- Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
- Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.
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Part I: Patients are randomized to 1 of 2 treatment arms.
- Arm I: 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.
- Arm II: 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.
Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.
Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.
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Part II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
- Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3010 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2001 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 6 FEC
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.
|
Biological: Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
Other Name: Herceptin
Drug: Cyclophosphamide
500 mg/m², D1 and every 3 weeks
Drug: Epirubicin
100 mg/m², D1 and every 3 weeks
Other Name: epirubicin hydrochloride
Drug: Fluorouracil
500 mg/m², D1 and every 3 weeks
|
Experimental: 6 DE
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
|
Biological: Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
Other Name: Herceptin
Drug: docetaxel
on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks
Drug: Epirubicin
100 mg/m², D1 and every 3 weeks
Other Name: epirubicin hydrochloride
|
- Progression Free Survival [ Time Frame: 5 years from randomization ]
- Herceptin safety [ Time Frame: 5 years from randomization ]
- Overall survival [ Time Frame: 5 years from randomization ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054587
France | |
Centre Paul Papin | |
Angers, France, 49036 | |
Centre Hospitalier d'Annecy | |
Annecy, France, 74011 Cedex | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
C.H. Bourg En Bresse | |
Bourg En Bresse, France, 01012 | |
Centre Regional Francois Baclesse | |
Caen, France, 14076 | |
Centre Jean Perrin | |
Clermont-Ferrand, France, 63011 | |
Hopital Intercommunal De Creteil | |
Creteil, France, 94010 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
Dijon, France, 21079 | |
Institut Prive de Cancerologie | |
Grenoble, France, 38100 | |
Clinique du Petit Colmouilins | |
Harfleur, France, 76700 | |
Centre Hospitalier de Lagny | |
Lagny Sur Marne, France, 77405 | |
Hopital Andre Mignot | |
Le Chesnay, France, 78157 | |
CMC Les Ormeaux | |
Le Havre, France, 76600 | |
Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 | |
Centre Hospitalier Regional Metz Thionville | |
Metz, France, 57038 | |
Centre Hospitalier General Andre Boulloche | |
Montbeliard, France, 25209 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
Centre Hospitalier de Mulhouse | |
Mulhouse, France, 68051 | |
Centre Regional Rene Gauducheau | |
Nantes-Saint Herblain, France, 44805 | |
Hopital Avicenne | |
Paris, France, 75674 | |
Clinique Saint - Pierre | |
Perpignan, France | |
CHU Poitiers | |
Poitiers, France, 86021 | |
Institut Jean Godinot | |
Reims, France, 51056 | |
Centre Eugene Marquis | |
Rennes, France, 35042 | |
Clinique Sainte Clotilde | |
Sainte Clotilde, France, 97492 | |
Centre Paul Strauss | |
Strasbourg, France, 67065 | |
Hopitaux Universitaire de Strasbourg | |
Strasbourg, France, 67091 | |
Institut Claudius Regaud | |
Toulouse, France, 31052 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 |
Study Chair: | Marc Spielmann, MD | Gustave Roussy, Cancer Campus, Grand Paris |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UNICANCER |
ClinicalTrials.gov Identifier: | NCT00054587 History of Changes |
Other Study ID Numbers: |
UC-0140/0005 - PACS 04 FRE-FNCLCC-PACS-04/0005 EU-20236 PACS04 ( Other Identifier: UNICANCER ) |
First Posted: | February 6, 2003 Key Record Dates |
Last Update Posted: | July 19, 2013 |
Last Verified: | July 2013 |
Keywords provided by UNICANCER:
stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Trastuzumab Epirubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators Antimetabolites Antimetabolites, Antineoplastic Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |