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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011023
Receipt No. R000012906
Scientific Title A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)
Date of disclosure of the study information 2013/06/24
Last modified on 2015/05/28

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Basic information
Public title A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)
Acronym "TRAstuzumab and ANAstrozole for breast cancer" WJOG7412B/Tra-Ana study
Scientific Title A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)
Scientific Title:Acronym "TRAstuzumab and ANAstrozole for breast cancer" WJOG7412B/Tra-Ana study
Region
Japan

Condition
Condition Hormone receptor-positive, HER2-positive postmenopausal breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating efficacy and safety of neoadjuvant combination therapy of trastuzumab and anastrozole in resectable hormone receptor-positive, HER2-positive postmenopausal breast cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate
Key secondary outcomes Safety, Response rate, Disease free survival, Overall survival, Breast conserving rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Neoadjuvant Combination therapy of Trastuzumab and Anastrozole
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)Pathologically confirmed resectable breast cancer Stage I-IIIB (T1-4 and N0-1)
2)Resectable at the day of enrollment
3)Hormone receptor-positive and HER2-positive (3+ staining by IHC or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed by pathology.
4)ECOG performance status 0-1
5)Postmenopausal (amenorrhea for at least one year/menopause due to bilateral ovariectomy)
6)Previously untreated with trastuzumab or aromatase inhibitors
7)No previous surgery or radiation therapy for ipsilateral breast
8)Adequate baseline organ and marrow function as defined below:
Absolute neutrophil count >= 1.5x10^9/L
Hemoglobin >= 9.0g/dL
AST and ALT <= 100IU/L
Serum bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
9)Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography
10)Signed written informed consent
Key exclusion criteria 1)Active infection under treatment
2)Concurrent serious disease or condition
3)Pulmonary fibrosis or interstitial pneumonitis by chest X-ray
4)Abnormal electrocardiography findings with clinical symptoms
5)Patients with other active malignancies
6)Concurrent serious psychiatric disorder
7)Concurrent massive body cavity fluid (pleural effusion, ascites or cardiac effusion, etc)needs treatment
8)Concurrent continuous systemic treatment with steroids
9)History of serious allergic reactions
10)HBsAg or HCVAb-positive
11)Patient considered irrelevant by the attending physician for the study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Shimomura
Organization National Cancer Center Hospital
Division name Dept. of Experimental Therapeutics
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL 03-3542-2511
Email akihiko-sig@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacente
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 24 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
2013 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 24 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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