UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050208 |
|---|---|
| Receipt number | R000057177 |
| Scientific Title | A prospective study to examine the expression status of circulating tumor DNA in patients with high-risk early breast cancer and its association with metastasis and recurrence |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/02/13 17:26:43 |
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Basic information
Public title
A prospective study to examine the expression status of circulating tumor DNA in patients with high-risk early breast cancer and its association with metastasis and recurrence
Acronym
Breast cancer ctDNA Landmark study
Scientific Title
A prospective study to examine the expression status of circulating tumor DNA in patients with high-risk early breast cancer and its association with metastasis and recurrence
Scientific Title:Acronym
Breast cancer ctDNA Landmark study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the correlation between MRD detection frequency and recurrence by ctDNA analysis (Guardant Revea) in patients with high-risk recurrent breast cancer after completion of perioperative treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ctDNA positive rate at 1-6 months after completion of definitive 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age at the time of obtaining written consent is 20 years or older
2. Histologically diagnosed invasive breast cancer
3. Stage I-III without distant metastasis, see below for eligibility criteria for each subtype
4. Planned, undergoing, or after surgery and standard definitive treatment
Standard curative treatments include radiotherapy, chemotherapy, anti-HER2 therapy, immune checkpoint inhibitors, PARP inhibitors, CDK4/6 inhibitors, etc. Endocrine therapy is not considered. Treatment selection is based on the judgment of the attending physician in accordance with various guidelines. Patients with a high risk of recurrence who cannot be treated with standard systemic drug therapy for any reason, such as age or pre-existing conditions, are eligible if surgery has been performed.
5. Satisfy any definition of high risk of recurrence by subtype below
i. ER positive/HER2 negative
a. 4 or more lymph node metastases
b. 1-3 lymph node metastases with either tumor diameter >=5 cm or histological grade >=3 or Ki-67 >=20%
c. Remaining invasive cancer in the breast or axillary lymph nodes at the time of surgery if preoperative chemotherapy was performed
d. Diagnosed as high risk of recurrence by polygene assay
ii. HER2 positive
a. Lymph node metastasis positive
b. Tumor diameter >=2 cm
c. Remaining invasive cancer in the breast or axillary lymph nodes after preoperative chemotherapy
iii. ER/PgR/HER2 negative
a. Lymph node metastasis positive
b. Tumor diameter >=2 cm
c. Remaining invasive cancer in the breast or axillary lymph nodes after preoperative chemotherapy
Key exclusion criteria
1 More than 6 months have passed since the completion of radical treatment
2 Having multiple cancers (excludes carcinoma in situ of the skin other than malignant melanoma)
3. Pregnancy, history of organ transplantation, or other conditions that affect ctDNA analysis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Breast Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Breast Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Guardant Health
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2023 | Year | 02 | Month | 13 | 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
| 2022 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057177
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