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

This study has suspended participant recruitment.

(Due to an adverse event revelation.)

Sponsor:

Collaborator:

Osaka University Hospital

Information provided by:

Translational Research Informatics Center, Kobe, Hyogo, Japan

ClinicalTrials.gov Identifier:

NCT01262274

First received: December 15, 2010

Last updated: August 15, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2010

Last Updated Date

August 15, 2012

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response Rate (confirmed by calipers CT or MRI) [ Time Frame: six months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01262274 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor [ Time Frame: seven months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: Anastrozole
ANA is given 1mg daily for 24 weeks.
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.

Study Arm (s)

Active Comparator: ANA
Intervention: Drug: Anastrozole
Experimental: ANA+UFT
Intervention: Drug: Anastrozole plus tegafur-uracil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01262274

Other Study ID Numbers ^ICMJE

TRIBC1009

Has Data Monitoring Committee

Yes

Responsible Party

Shinzaburo Noguchi / Professor, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine

Study Sponsor ^ICMJE

Translational Research Informatics Center, Kobe, Hyogo, Japan

Collaborators ^ICMJE

Osaka University Hospital

Investigators ^ICMJE

Principal Investigator:

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

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

Information Provided By

Translational Research Informatics Center, Kobe, Hyogo, Japan

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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