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

Breast Neoplasms Clinical Trial

— Neo-ACET BC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262274
• Other study ID #: TRIBC1009
• Status: Terminated
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: May 19, 2015
• Start date: December 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: April 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Anastrozole
ANA is given 1mg daily for 24 weeks.
• Anastrozole plus tegafur-uracil
ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.

Locations

Country	Name	City	State
Japan	Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine	Osaka city	Osaka prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Department of breast and endocrine surgery graduate school of Medicine Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (confirmed by calipers CT or MRI)		six months	No
Secondary	Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor		seven months	Yes