UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046338 |
|---|---|
| Receipt number | R000042522 |
| Scientific Title | Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer. |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2022/12/15 12:40:50 |
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Basic information
Public title
Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.
Acronym
Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.
Scientific Title
Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.
Scientific Title:Acronym
Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.
Region
| Japan |
Condition
Condition
HER2 positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Investigate pCR rate for breast cancer patients received neoadjuvant chemotherapy using T-mab and P-mab containing regimen followed by anthracyclines.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pCR rate (defined as (ypT0/is and ypN0)
Key secondary outcomes
Tumor reduction rate of docetaxel + T-mab + P-mab, tumor reduction rate of docetaxel + T-mab + P-mab followed by anthracyclin based regimen.
DFS, safety, cardiotoxicity, and DFS of patients received only docetaxel + T-mab + P-mab.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) HER2 positive breast cancer patients diagnosed pathologically (IHC HER2 3+ or HER2 2+/FISH positive).
2) Patients indicated to neoadjuvant chemotherapy.
3) Patients must have Eastern Cooperative Oncology group (ECOG) Performance Status 0 or 1.
Key exclusion criteria
1) Patients with active other cancers required to treat.
2) Patients with heart function failure (EF<60%).
3) Patients determined as being an inappropriate case by the investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo city
TEL
011-611-2111
simahiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo city
TEL
011-611-2111
Homepage URL
simahiro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Clinical Trial Center, Sapporo Medical University
Address
S1, W16, Chuo-ku, Sapporo city
Tel
011-611-2111
simahiro@sapmed.ac.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
| 2021 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/10.3892/etm.2022.11767
Number of participants that the trial has enrolled
24
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
