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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)

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Anastrozole
Anastrozole plus tegafur-uracil
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ANA

ANA+UFT

Arm Description

Outcomes

Primary Outcome Measures

Response Rate (confirmed by calipers CT or MRI)

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2010
Last Updated
May 19, 2015
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Department of breast and endocrine surgery graduate school of Medicine Osaka University
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1. Study Identification

Unique Protocol Identification Number
NCT01262274
Brief Title
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to an adverse event revelation.
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Department of breast and endocrine surgery graduate school of Medicine Osaka University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANA
Arm Type
Active Comparator
Arm Title
ANA+UFT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
ANA is given 1mg daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Anastrozole plus tegafur-uracil
Intervention Description
ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.
Primary Outcome Measure Information:
Title
Response Rate (confirmed by calipers CT or MRI)
Time Frame
six months
Secondary Outcome Measure Information:
Title
Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
Time Frame
seven months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinzaburo Noguchi, M.D., Ph.D.
Organizational Affiliation
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
City
Osaka city
State/Province
Osaka prefecture
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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