UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062935 |
|---|---|
| Receipt number | R000072059 |
| Scientific Title | A prospective randomized trial on the omission of axillary lymph node dissection in ultrasound-detectable axillary metastases in primary breast cancer treated by upfront surgery |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/15 17:15:24 |
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Basic information
Public title
A prospective randomized trial on the omission of axillary lymph node dissection in ultrasound-detectable axillary metastases in primary breast cancer treated by upfront surgery
Acronym
SENOMAC-ULTRA trial
Scientific Title
A prospective randomized trial on the omission of axillary lymph node dissection in ultrasound-detectable axillary metastases in primary breast cancer treated by upfront surgery
Scientific Title:Acronym
SENOMAC-ULTRA trial
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of replacing upfront ALND with an upfront TAD in patients with confirmed nodal involvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence-free survival (RFS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Upfront targeted axillary dissection (TAD), which includes a sentinel lymph node biopsy implying also the removal of nodes suspicious on intraoperative palpation, and the removal of the targeted node/s, i.e., the confirmed metastasis/es that is preoperatively marked. Adjuvant treatment, i.e. systemic treatment and radiotherapy, is given according to national or regional guideline
Interventions/Control_2
Patients assigned to the control group undergo upfront ALND of anatomical levels 1 and 2 with the aim to remove at least ten lymph nodes. Suspicious or confirmed nodal metastases in the internal mammary or periclavicular space are not routinely removed. Patients in whom the postoperative histopathology report identifies fewer than ten nodes are not excluded from the trial but handled in sensitivity analyses. In case a participant has already received an axillary marker before randomization, we discourage from using this marker for localisation or intraoperative identification of the confirmed
metastasis, i.e., a standard ALND should be performed. Specimen radiography is therefore not recommended.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary invasive breast cancer clinical stageII-III
2. Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy
3. Written informed consent
Key exclusion criteria
1. Distant metastases
2. Ipsilateral metastases in internal mammary, infra- or supraclavicular lymph nodes without confirmed axillary nodal involvement
3. Inflammatory or locally advanced breast cancer
4. Nodes fixed to each other or to neighbouring structures on palpation or imaging
5. History of contralateral invasive breast cancer within 5 years
6. Bilateral invasive breast cancer if (i) any side meets any exclusion criteria or if (ii) both sides meet all inclusion criteria
7. Pregnancy
8. Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy <three months is allowed)
9. Medical contraindications for or expressed preoperative wish to abstain from radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration
10. Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
Target sample size
1380
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shien |
Organization
Okayama University Hospital
Division name
Breast and Endocrine Surgery
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357265
tshien@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shien |
Organization
Okayama University Hospital
Division name
Breast and Endocrine Surgery
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357265
Homepage URL
tshien@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 7008558
Tel
0862357265
tshien@md.okayama-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
| 2026 | Year | 11 | Month | 01 | 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
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2041 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072059
