Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Anastrozole
* Drug: Anastrozole plus tegafur-uracil


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANA<br> | Drug: Anastrozole<br>* ANA is given 1mg daily for 24 weeks.<br>|
| Experimental: ANA+UFT<br> | Drug: Anastrozole plus tegafur-uracil<br>* ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (confirmed by calipers CT or MRI) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor |  | seven months |