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

NCT01262274 | Terminated Phase 2 DMC

• 1 other identifier: TRIBC1009
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Response Rate (confirmed by calipers CT or MRI)

  six months

Secondary Outcomes (1)

• Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor

  seven months

Study Arms (2)

ANA

ACTIVE COMPARATOR

Drug: Anastrozole

ANA+UFT

EXPERIMENTAL

Drug: Anastrozole plus tegafur-uracil

Interventions

Anastrozole DRUG

ANA is given 1mg daily for 24 weeks.

ANA

Anastrozole plus tegafur-uracil DRUG

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

ANA+UFT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Department of breast and endocrine surgery graduate school of Medicine Osaka University: collaborator

Study Sites (1)

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

Osaka, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Tegafur

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines

Study Officials

• Shinzaburo Noguchi, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

JP (1)