UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051093 |
|---|---|
| Receipt number | R000058249 |
| Scientific Title | Optimization of preoperative chemotherapy for breast cancer using whole genome sequencing -prediction of pathological complete response and exploration of a novel target for patients with non-pathological complete response- |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/12/25 09:26:07 |
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Basic information
Public title
Optimization of preoperative chemotherapy for breast cancer using whole genome sequencing
-prediction of pathological complete response and exploration of a novel target for patients with non-pathological complete response-
Acronym
Breast Cancer Whole Genome Study
Scientific Title
Optimization of preoperative chemotherapy for breast cancer using whole genome sequencing
-prediction of pathological complete response and exploration of a novel target for patients with non-pathological complete response-
Scientific Title:Acronym
Breast Cancer Whole Genome Sequencing Study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To optimize perioperative treatment for breast cancer patients with triple negative breast cancer and luminal breast cancer who receive preoperative chemotherapy as standard treatment, by performing whole genome sequence using tumor tissue to identify genomic and immunological factors that predict pCR, and to explore novel target molecules for non-pCR cases.
Basic objectives2
Others
Basic objectives -Others
To identify genetic and immunological candidate factors that predict efficacy of postoperative treatment in patients with non-pCR
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identify genomic and immunological factors that correlate with pCR in preoperative treatment
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are 18 years of age or older at the time of consent
2. Patients who have been fully informed of the details of this study and have given their written consent.
3. Histologically or cytologically confirmed invasive breast cancer
4. Clinical stage II-III breast cancer
5. Immunohistochemistry have shown hormone receptor-positive or negative breast cancer
6. Immunohistochemistry have shown HER2-negative breast cancer
7. Patient is scheduled to receive preoperative therapy with anthracycline, taxane with or without pembrolizumab, etc.
8. Performance status (PS) is 0-2 by ECOG criteria
9. Organ function is preserved
Key exclusion criteria
1. Patients with a history of invasive malignancy within the past 3 years from the time consent was obtained.
2. Have an active infection requiring systemic treatment.
3. Have poorly controlled diabetes mellitus or hypertension.
4. Patients with unstable angina, myocardial infarction within 6 months, or clinically significant arrhythmia requiring treatment.
5. Congestive heart failure, poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy consistent with New York Heart Association (NYHA) Classification II or higher.
6. Receiving continuous systemic administration of steroids " exceeding 10mg/day of prednisolone equivalent"or immunosuppressive agents.
7. Other cases deemed inappropriate by the physician in charge.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shigehisa |
| Middle name | |
| Last name | Kitano |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Advanced Medical Development
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Shigehisa.kitano@jfcr.or.jp
Public contact
Name of contact person
| 1st name | datacenter |
| Middle name | |
| Last name | West Japan Oncology Group |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka ,JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
The 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
Japanese Foundation for Cancer Research, Secretariat of the Medical Research Ethics Review Committee
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
03-3520-0111
med.shinsa@jfcr.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
| 2023 | Year | 05 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the association between whole genome analysis of breast cancer and pathologic complete response after preoperative chemotherapy.
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058249
