Breast Cancer
Conditions
Interventions
Premenopausal patients
Chemotherapy+estrogen deprivation group 1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously,then 2)FEC100 ( 500mg/m2 of 5-FU, 100mg/m2 of epi-ADM, 500mg/m2 of CPA) is given once
Chemotherapy group 1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously, then 2)FEC100 ( 500mg/m2 of 5-FU, 100mg/m2 of epi-ADM, 500mg/m2 of CPA) is given once a three weeks for 1
Chemotherapy group 1)Eighty mg/m2 of Taxol once a week for 12 weeks are given intravenously,then 2)FEC100(500mg/m2 of 5-FU,100mg/m2 of epi-ADM, 500mg/m2 of CPA)is given once a three weeks for 12week
Sponsors
THE FIRST
Hirosima city Hosp.Chugoku central Hosp.Kagawa Rosai Hosp.Himeji Red Cross Hosp.Okayama Saiseikai Gen.HP et al.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion Criteria Eligible patients should meet all of the followings. 1)Eligible patients have histologically confirmed breast cancer who have no metastatic lesions except axillary lymphnode(s). 2)Tumor is larger than 2cm by any means of diagnostic imaging. 3)Patients with Performance status of 0 or 1(ECOG). 4)Patients should be older than 20 yrs. 5)No history of previous treatment of the present illness (chemotherapy, hormonal therapy, irradiation or surgery). Hormone replacement therapy is allowed if it has been discontinued 6 months before the trial. 6)Normal organ function with the following values; 1.WBC; greater than 4,000/mm3 or Neutrophil;greater than 2,000/mm3 2.PLT;greater than 10,000/mm3 3.Hgb;greater than 9.0g/dl 4.AST and ALT;no more than twice of the normal limit set by each insutitute. 5.T Bil.;no more than x 1.25 times of the normal limit set by each institute 6.Serum creatinine;no more than 1.5 times of the normal limit set by each institute. 7.Ejection fraction (EF) : greater than 60percent 8.ECG;normal without serious heart disease and arrhythmia. 7)Obtained written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1)Previous history of treatment with taxol, Anthracyclines and hormonal treatment. 2)Infection, uncontrollable diabetes mellitus, severe heart disease, angina with poor control, myocardial infarction within 6 months, active ulcers, multiple cancers, severe neuropathy or any other severe complications. 3)interstitial pneumonia and lung fibrous disease which needs treatment. 4)liver cirrhosis. 5)stage-4 disease with metastasis. 6)Pleural effusion, ascites, pericardial effusion. 7)Coagulopathy including DIC. Pregnancy , possibility of pregnancy and breast feeding. 8)History of severe allergic reactions. 9)allergy to Clemophor. 10)allergic to TXL, 5FU, EpiADM, CPM, LHRH-A(premenopausal), exemestan (postmenopausal). 11)allergic to alcohol. 12)active multiple malignancies. 13)patients judged to be inadequate to accrue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of pathological CR | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of breast conservation operation, side effect, response rate, disease free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactJyunji Matsuoka M.D.,Ph.D.
The FIRST Department of Gastroenterological Surgery Transplant and Surgical Oncology, Okayama University
Outcome results
None listed