Status:
TERMINATED
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Department of breast and endocrine surgery graduate school of Medicine Osaka University
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone the...
Eligibility Criteria
Inclusion
- Histologically-confirmed diagnosis of invasive breast cancer
- Clinical stage T2, N0 or N1, M0 (TNM Classification)
- Patients must be postmenopausal
- Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
- ECOG Performance status (PS) 0 or 1
- Patients must be able to swallow tablets and capsules
- Candidates for mastectomy or breast-conserving surgery
- Adequate bone marrow, liver and renal function
- Written informed consent was obtained from all patients before randomization.
Exclusion
- Inoperable, bilateral or inflammatory breast cancer
- multiple carcinoma
- Personal history of invasive carcinoma
- Patients receive systemic therapy of corticosteroid
- Patients receive estrogen preparation or raloxifene
- Patients with other concurrent severe and/or uncontrolled medical disease
- Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01262274
Start Date
December 1 2010
End Date
April 1 2014
Last Update
May 21 2015
Active Locations (1)
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1
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Osaka, Osaka, Japan, 565-0871