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
18 Years
64 Years
Female
Breast Cancer
Trial Information
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
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.
- 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.
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Marc Spielmann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
CDR0000269909
NCT ID:
NCT00054587
Start Date:
June 2001
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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