UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057643 |
|---|---|
| Receipt number | R000065862 |
| Scientific Title | A prospective study to evaluate clinical outcomes of targeted axillary dissection after neoadjuvant chemotherapy in Node-positive breast cancer patients |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/04/17 16:06:06 |
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Basic information
Public title
A prospective study to evaluate clinical outcomes of targeted axillary dissection after neoadjuvant chemotherapy in Node-positive breast cancer patients
Acronym
Axillary evaluation with targeted axillary dissection
Scientific Title
A prospective study to evaluate clinical outcomes of targeted axillary dissection after neoadjuvant chemotherapy in Node-positive breast cancer patients
Scientific Title:Acronym
Axillary evaluation with targeted axillary dissection
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, axillary recurrence rate, and incidence of complications in TAD when neoadjuvant chemotherapy (NAC) is administered in patients with axillary lymph node metastasis from breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, axillary recurrence rate, and complication rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After placing a marker in the axillary lymph nodes with metastasis, neoadjuvant chemotherapy is performed. The lymph nodes with the marker and the sentinel lymph nodes are removed at the time of surgery, and when both are negative for metastasis, no axillary lymph node dissection is performed.
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
Patients diagnosed with breast cancer with 1-3 metastases in the axillary lymph nodes and scheduled for neoadjuvant chemotherapy
Key exclusion criteria
1. Women who are pregnant, may be pregnant, within 28 days of giving birth, or breastfeeding.
2. Those who suffer from a psychiatric disorder or symptoms that interfere with their daily life and are deemed to have difficulty participating in the study.
3. Those who the principal investigator judges to be inappropriate as study subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumi |
| Middle name | |
| Last name | Murakami |
Organization
Juntendo University Nerima Hospital
Division name
Department of Breast Surgery
Zip code
1778521
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
fmuraka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Murakami |
Organization
Juntendo University Nerima Hospital
Division name
Department of Breast Surgery
Zip code
1778521
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
Homepage URL
fmuraka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Nerima Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Nerima Hospital
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
Tel
03-5923-3111
gcp@juntendo-nerima.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
| 2025 | Year | 04 | Month | 17 | 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
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2033 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065862
