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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028065
Receipt No. R000032085
Scientific Title Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2017/07/02

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Basic information
Public title Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer
Acronym PASSION trial
Scientific Title Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer
Scientific Title:Acronym PASSION trial
Region
Japan

Condition
Condition HER2-positive HR-negative breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the pathological response after preoperative sequential chemo-radiotherapy in HER2-positive HR-negative early breast cancer, and the ability of HSD17B4-hypermethylation to predict pathological complete response (pCR)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pCR rate in HSD17B4-hypermethylated breast cancer
Key secondary outcomes

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 Other
Interventions/Control_1 Trastuzumab-containing chemotherapy followed by whole breast irradiation, then surgery.
Chemotherapy is sequential treatment of anthracyclines and taxanes with tarastuzumab or TCH.

Select one of the following anthracycline regimens; AC, EC, FAC, FEC and Dose dense AC

Select one of the following taxane with tarastuzumab regimens; PTX/T-mab and DTX/T-mab
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
75 years-old >=
Gender Female
Key inclusion criteria 1. Histologically confirmed invasive breast cancer
2. Clinical stage T1 to T3
3. Clinical stage N0 and N1
4. Non-metastatic operable breast cancer
5. HER2 positive
6. Hormone receptor negative
7. Age between 20 and 75
8. Eastern Cooperative Oncology Group performance status of 0 to 1
9. No previous treatment history of chemotherapy, endocrine therapy, trastuzumab and radiotherapy
10. Left ventricular ejection fraction by echocardiogram or multigated acquisition scan of 55% and higher within 4 weeks before registration
11. Preserved organ functions
12. Signed written informed consent
Key exclusion criteria 1. Active other malignancies
2. Bilateral breast cance
3. Multicentric tumors
4. History of congestive heart failure or myocardial infarction, arrhythmia or heart valvular disease requiring treatment
5. Clinically significant infection
6. Pregnant or breast-feeding women, women of childbearing potential
7. Diabetes uncontrolled or requiring insulin
8. Systemic sclerosis or systemic lupus erythematosus
9. Systemic use of steroids or immunosuppressive agents
10. Unsuitable mental status for participation
11. Ineligible based on decision of an investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Mukai
Organization National Cancer Center Hospital East
Division name Division of Breast and Medical oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba
TEL 04-7133-1111
Email hrmukai@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Shinano
Organization Comprehensive Support Project Oncological Research of Breast Cancer
Division name Administration Office
Zip code
Address Gakkikaikan, 2-18-21 Soto-Kanda, Chiyoda-ku, Tokyo
TEL 03-5294-7288
Homepage URL
Email office-bc@cspor-bc.or.jp

Sponsor
Institute Japan Agency for Medical Research and development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 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
2017 Year 07 Month 04 Day
Last modified on
2017 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032085

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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