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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
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: Anastrozole
Drug: Anastrozole plus tegafur-uracil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

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

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

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ANA Drug: Anastrozole
ANA is given 1mg daily for 24 weeks.
Experimental: ANA+UFT 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262274

Locations
Japan
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Osaka city, Osaka prefecture, Japan, 565-0871
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Osaka University Hospital
Investigators
Principal Investigator: Shinzaburo Noguchi, M.D. , Ph.D. Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Shinzaburo Noguchi / Professor, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01262274     History of Changes
Other Study ID Numbers: TRIBC1009
Study First Received: December 15, 2010
Last Updated: August 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tegafur
Anastrozole
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013