Breast Neoplasms
Conditions
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.
Interventions
DRUGAnastrozole
ANA is given 1mg daily for 24 weeks.
DRUGAnastrozole plus tegafur-uracil
ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.
Sponsors
Department of breast and endocrine surgery graduate school of Medicine Osaka University
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (confirmed by calipers CT or MRI) | six months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor | seven months |
Countries
Japan
Outcome results
None listed