Overview

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

Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator:
Department of breast and endocrine surgery graduate school of Medicine Osaka University
Treatments:
Anastrozole
Tegafur
Criteria
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.