A Randomized Multicenter Phase2 Trial of Neoadjuvant Paclitaxel followed by Fluorouracil,Epirubin,and Cyclophosphamide(FEC)with or without Estrogen Deprivation by LH-RH agonist or Aromatase Inhibitor in Breast Cancer larger than 2 cm.

UMIN ID: UMIN000000748

Registered date:30/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2007/04/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 a three weeks for 12weeks. 3)3.75mg/body of LHRH-A once a month for 6 months is given subdermally initiated within 2 weeks of the first Taxol.
Premenopausal patients; 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 12weeks.
Postmenopausal patients; 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 12weeks. 3)Twenty-five mg a day of Exemestan is given orally initiated within 2 weeks of the first Taxol for consecutive 6 months until one day before the operation.
Postmenopausal patients 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 12weeks

Outcome(s)

• Primary Outcome: The rate of pathological CR
• Secondary Outcome: The rate of breast conservation operation, side effect, response rate, disease free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: THE FIRST
• Secondary Sponsor: Hirosima city Hosp.Chugoku central Hosp.Kagawa Rosai Hosp.Himeji Red Cross Hosp.Okayama Saiseikai Gen.HP et al.
• Source(s) of Monetary Support: None