UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028065 |
|---|---|
| Receipt number | 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 | 2022/06/28 13:44:57 |
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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 | Hirofumi |
| Middle name | |
| Last name | Mukai |
Organization
National Cancer Center Hospital East
Division name
Division of Breast and Medical oncology
Zip code
277-0882
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba
TEL
04-7133-1111
hrmukai@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | secretariat |
| Middle name | |
| Last name | Comprehensive Support Project Oncological Research of Breast Cancer |
Organization
Comprehensive Support Project Oncological Research of Breast Cancer
Division name
Administration Office
Zip code
277-0871
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa
TEL
04-7135-5609
Homepage URL
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
Japan Agency for Medical Research and development
Institute
Department
Personal name
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
CSPOR-BC
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa City, Chiba Prefecture
Tel
04-7135-5609
office-bc@cspor-bc.or.jp
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
80
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 29 | Day |
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
| 2022 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032085
