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.

Phase 2

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000000748
• Lead Sponsor: THE FIRST

Brief Summary

The primary endpoint was the pathological complete response (pCR) rate after neoadjuvant therapy. Twenty-eight patients were randomized. There were no significant differences in pCR rate between the concurrent group (12.5%;2/16) and the chemotherapy alone group (8.3%;1/12). Tumor size after therapy was significantly reduced in the concurrent therapy group (p=0.035), but not in the chemotherapy-alone group (p=0.622). Neoadjuvant chemotherapy with concurrent hormone therapy provided no significant improvement in pCR rate in ER-positive breast cancers. These preliminary results should be followed up by further studies.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-30
• Study Completion: 2017-06-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified