JPRN-UMIN000000748CompletedPhase 2
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. - 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 2cm. (NACED Randomized Multicenter Phase2 Trial)
THE FIRST0 sites120 target enrollmentStarted: June 30, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- Female
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
Investigators
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