NIPH Clinical Trials Search

JRCT ID: jRCTs061220113

Registered date:29/03/2023

TAS trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment14/04/2023
Target sample size300
Countries of recruitment
Study typeInterventional
Intervention(s)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 metastasis and a lymph node labeled as sentinel lymph node.


Primary OutcomeRate of non-TAS lymph node metastasis
Secondary Outcome1 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 74age old
Include criteriaThose 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
Exclude criteria1 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

Related Information


Public contact
Name Shien Tadahiko
Address 2-5-1Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7265
Affiliation Okayama University Hospital
Scientific contact
Name Tadahiko Shien
Address 2-5-1Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7265
Affiliation Okayama University Hospital