UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030510 |
|---|---|
| Receipt number | R000034829 |
| Scientific Title | Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2025/06/30 14:00:37 |
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Basic information
Public title
Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study
Acronym
Sentinel lymph node biopsy after neoadjuvant therapy in node-positive breast cancer
Scientific Title
Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study
Scientific Title:Acronym
Sentinel lymph node biopsy after neoadjuvant therapy in node-positive breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year axillary lymph node relapse free survival
Key secondary outcomes
Diagnostic potential of SNB
3-year disease-free and overall survival
Relation between relapse site and clinicopathological factor
Rate of arm lymphedema
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
| Maneuver |
Interventions/Control_1
Sentinel lymph node biopsy
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
Female
Key inclusion criteria
Aquired clinical node negative breast cancer after neoadjuvant therapy
Key exclusion criteria
Inoperable case
Inflammatory breast cancer
Progressive disease after neoadjuvant therapy
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Ogawa |
Organization
Osaka City General Hospital
Division name
Department of Breast Surgical Oncology
Zip code
534-0021
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
yos-ogawa@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Ogawa |
Organization
Osaka City General Hospital
Division name
Department of Breast Surgical Oncology
Zip code
534-0021
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
Homepage URL
yos-ogawa@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka City General Hospital
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
IRB, Osaka City General Hospital
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
Tel
06-6929-3269
xc0017@osakacity-hp.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
大阪市立総合医療センター（大阪府）、大阪市立大学医学部付属病院（大阪府）、住友病院（大阪府）、石切生喜病院（大阪府）、市立柏原病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
osakacity-hp.or.jp/ocgh/dep/sup/chiken/index.html
Publication of results
Published
Result
URL related to results and publications
jbcs.members-web.com/contents/3
Number of participants that the trial has enrolled
20
Results
Two of 20 enrolled patients failed. And 18patients were analyzed. Mean number of removed sentinel nodes(SN) was three. Fifteen patients were diagnosed as SN-negative, and they were omitted axillary nodes dissection(ALND). Three patients were diagnosed as SN-positive, and they underwent ALND. 3-year lymph node-relapse free survival rate was 100%. 3-year relapse free survival rate was 83.3%. With a median follow up term fo 52 months, overall survival rate was 94.9%.
Results date posted
| 2025 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 patients with breast cancer (at pre- neoadjuvant chemotherapy, stage II: 14 cases, stage III: 4 cases, Luminal type: 7 cases, Luminal-Her: 5 cases, Her2: 3 cases, Triple Negative : 3 cases.)
Participant flow
The standard treatments for breast cancer were performed after surgery.
Adverse events
none
Outcome measures
3-year lymph node-relapse free survival rate, 3-year relapse free survival rate, and overall survival rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2017 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034829
