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TAS trial

Feasibility study of Tailored axillary surgery (TAS) for clinical node-positive breast cancer patients.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061220113
Enrollment
300
Registered
2023-03-29
Start date
2023-04-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer cN+, Breast cancer

Interventions

TAS (targetted axillary dissection) Usually, axillary lymph node dissection separates the lymph nodes to be removed into TAS and the remaining lymph nodes. TAS is a lymph node labeled with apparent me
Targetted axillary dissection

Sponsors

Shien Tadahiko
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Those who meet all of the following criteria are eligible 1 Histologically diagnosed invasive breast cancer in the primary lesion of breast cancer 2 Surgery is scheduled as initial treatment 3 The lymph node most suspected of metastasis is pathologically diagnosed as metastasis by cytology or needle biopsy 4 There are 1 3 lymph nodes suspected of metastasis in diagnostic imaging 5 No suspicion of metastasis in all levels II III Rotter endothorax and supracraclavicular lymph nodes 6 The clinical classification of the primary tumor is T1 3 7 Women who are at least 18 years old and 74 years of age or younger on the date of registration 8 Performance status is 0 or 1 in the ECOG criterion 9 The test value within 28 days before registration satisfies 10 Bilateral breast cancer regardless of metachronous or simultaneity 11 Patients can receive standard radiotherapy and systemic drug therapy after surgery 12 Written consent has been obtained from the patient to participate in the study

Exclusion criteria

Exclusion criteria: 1 Active multiple cancers (simultaneous double cancers/multiple cancers and metachronous duplication with a disease-free period of up to 5 years) Cancer/Multiple Carcinoma. However, even if the disease-free period is less than 5 years, the patient has a complete response to radiation therapy. History of stage 0 beds, stage I laryngeal cancer, or cancer that has been completely resected and has a 5-year relative survival rate of 95% or more is not included in active multiple/multiple cancers). 2 Infectious disease requiring systemic treatment. 3 Fever of 38.0C or higher at the time of registration. 4 Women who are pregnant, potentially pregnant, within 28 days after childbirth, or breastfeeding. 5 The applicant has a mental illness or psychiatric symptom that interferes with daily life and is judged to be difficult to participate in the study. 6 Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. 7 Complicated by uncontrolled diabetes. 8 Complicated by uncontrolled hypertension. 9 Unstable angina (angina pectoris that has developed or exacerbated seizures within the last 3 weeks) or has a history of myocardial infarction within 6 months. 10 Interstitial pneumonia, pulmonary fibrosis, severe emphysema, or more. 11 History of axillary surgery or irradiation 12 Other patients who are judged by the principal investigator or co-investigator to be inappropriate as research subjects

Design outcomes

Primary

MeasureTime frame
Rate of non-TAS lymph node metastasis

Secondary

MeasureTime frame
1 Identification rate of TAS 2 Identification rate of the targetted lymph node 3 Identification rate of the targetted lymph node according to procedure 4 rate of edema 5 QOL

Contacts

Public ContactShien Tadahiko

Okayama University Hospital

tshien@md.okayama-u.ac.jp+81-86-235-7265

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026