UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006434 |
|---|---|
| Receipt number | R000007636 |
| Scientific Title | Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer |
| Date of disclosure of the study information | 2011/09/29 |
| Last modified on | 2018/10/04 13:02:31 |
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Basic information
Public title
Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Acronym
Neo-ACET BC
Scientific Title
Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Scientific Title:Acronym
Neo-ACET BC
Region
| Japan |
Condition
Condition
Estrogen receptor (ER)-positive, HER2-negative postmenopausal primary breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for estrogen receptor (ER)-positive, HER2-negative postmenopausal primary breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical response rate
Key secondary outcomes
Reduction Rate
Pathological response
Breast-conserving surgery rate
Adverse event rate
Predictive factor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: Anastrozole (1mg/day) is administrated orally on 24 weeks daily.
Interventions/Control_2
Group B: Anastrozole (1mg/day) is administrated orally on 24 weeks. UFT (270mg/m2/day) is administrated orally on 24 weeks daily.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Histologically-confirmed diagnosis of invasive breast cancer
2.Clinical stage T2, N0 or N1, M0 (TNM Classification)
3.Patients must be postmenopausal
(1) Patients aged more than 60 years
(2) Patients aged more than 45 years and less than 60 years old with amenorrhea (more than one year).
(3) Patients who underwent bilateral oophorectomy.
4. ER-positive breast cancer (IHC: positive cells >= 10%)
5.HER2-negative breast cancer
(1) IHC:<=2
(2) FISH: negative
6.ECOG Performance status (PS) 0 or 1
7.Oral intake is possible
8.Candidates for mastectomy or breast-conserving surgery
9.Adequate bone marrow, liver and renal function
10.Written informed consent was obtained from all patients before randomization.
Key exclusion criteria
1.Inoperable, multiple, bilateral (synchronous or asynchronous) or inflammatory breast cancer
2.Personal history of invasive carcinoma
3.Patients receive systemic therapy of corticosteroid
4.Patients receive estrogen preparation or raloxifene
5.Patients with other concurrent severe and/or uncontrolled medical disease
6.Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinzaburo Noguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of breast and endocrine surgery
Zip code
Address
2-2 Yamadaoka , Suita, Osaka, Japan
TEL
06-6879-3772
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakayama |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of breast and endocrine surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL
06-6972-1181
Homepage URL
Sponsor or person
Institute
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Translational Research Informatics Center, Kobe, Hyogo, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01262274
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）、大阪府立急性期総合医療センター（大阪府）、大阪厚生年金病院（大阪府）、東大阪市立総合病院（大阪府）、NTT西日本大阪病院（大阪府）、大阪警察病院（大阪府）、日生病院（大阪府）、大阪府立成人病センター（大阪府）、八尾市立病院（大阪府）、大阪医療センター（大阪府）、大阪市立大学医学部附属病院（大阪府）、大阪労災病院（大阪府）、市立堺病院（大阪府）、りんくう総合医療センター（大阪府）、大阪医科大学附属病院（大阪府）、吹田市民病院（大阪府）、相原病院（大阪府）、慶應義塾大学医学部附属病院（東京都）、石川県立中央病院（石川県）、金沢大学附属病院（石川県）、兵庫医科大学病院（兵庫県）、関西労災病院（兵庫県）、京都府立医科大学附属病院（京都府）、相良病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007636
