UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048307 |
|---|---|
| Receipt number | R000055050 |
| Scientific Title | A prospective interventional study to evaluate the validity of sentinel node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis |
| Date of disclosure of the study information | 2022/07/28 |
| Last modified on | 2022/07/21 01:11:14 |
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Basic information
Public title
A prospective interventional study to evaluate the validity of sentinel node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis
Acronym
Ganken Breast center TAD study
Scientific Title
A prospective interventional study to evaluate the validity of sentinel node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis
Scientific Title:Acronym
Ganken Breast center TAD study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the validity of sentinel node biopsy + targeted lymph node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Axillary recurrence rate after omitting axillary dissection
Key secondary outcomes
Identification rate of SLN and targeted LN, distant disease-free survival rate, overall survival rate, accuracy for imaging diagnosis, the incidence of lymphedema, and incidence of sensory impairment of the upper limbs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
TAD(sentinel node biopsy + cytologicaly confirmed lymph node biopsy) for the candidates who achieved clinical node negative (ycN0) after NAC
Omit axillary dissection if intraoperative pathological diagnosis is negative for cancer cell
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cT1-3, cN1-3 (confirmed by aspiration cytology), M0(confirmed by PET-CT), primary breast cancer
ycN0 diagnosed by axillary ultrasound
ycN0 confirmed at a multidisciplinary conference
Key exclusion criteria
inflammatory breast cancer
cases in which lymph node evaluation is difficult
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ueno |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Surgical Oncology, Breast Oncology center
Zip code
1358550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
0335200111
takayuki.ueno@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Sakai |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Surgical Oncology, Breast Oncology center
Zip code
1358550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
0335200111
Homepage URL
takehiko.sakai@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital of JFCR
Breast Surgical Oncology, Breast Oncology center
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital of JFCR
Breast Surgical Oncology, Breast Oncology center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital of JFCR
Address
3-8-31, Ariake, Koto, Tokyo, Japan
Tel
0335200111
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
| 2022 | Year | 07 | Month | 28 | 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
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055050
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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