Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT01262274
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- 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 therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 57
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANA+UFT Anastrozole plus tegafur-uracil - ANA Anastrozole -
- Primary Outcome Measures
Name Time Method Response Rate (confirmed by calipers CT or MRI) six months
- Secondary Outcome Measures
Name Time Method Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor seven months
Trial Locations
- Locations (1)
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
🇯🇵Osaka city, Osaka prefecture, Japan