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

December 15, 2010
August 15, 2012
December 2010
June 2013   (final data collection date for primary outcome measure)
Response Rate (confirmed by calipers CT or MRI) [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262274 on ClinicalTrials.gov Archive Site
Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor [ Time Frame: seven months ] [ Designated as safety issue: Yes ]
Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
Not Provided
Not Provided
 
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • 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.
  • Active Comparator: ANA
    Intervention: Drug: Anastrozole
  • Experimental: ANA+UFT
    Intervention: Drug: Anastrozole plus tegafur-uracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
120
July 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01262274
TRIBC1009
Yes
Shinzaburo Noguchi / Professor, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Translational Research Informatics Center, Kobe, Hyogo, Japan
Osaka University Hospital
Principal Investigator: Shinzaburo Noguchi, M.D. , Ph.D. Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Translational Research Informatics Center, Kobe, Hyogo, Japan
August 2012

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