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

NCT ID: NCT01262274

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-04-30

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANA

Group Type: ACTIVE_COMPARATOR

Anastrozole

Intervention Type: DRUG

ANA is given 1mg daily for 24 weeks.

ANA+UFT

Group Type: EXPERIMENTAL

Anastrozole plus tegafur-uracil

Intervention Type: DRUG

ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.

Interventions

Anastrozole

ANA is given 1mg daily for 24 weeks.

Intervention Type: DRUG

Anastrozole plus tegafur-uracil

ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Department of breast and endocrine surgery graduate school of Medicine Osaka University

UNKNOWN

Sponsor Role: collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shinzaburo Noguchi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine

Locations

Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine

Osaka, Osaka, Japan

Countries

Japan

Other Identifiers

TRIBC1009

Identifier Type: -

Identifier Source: org_study_id