TAS trial

JRCT ID: jRCTs061220113

Registered date:29/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 14/04/2023
• Target sample size: 300
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Rate of non-TAS lymph node metastasis

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 74age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shien Tadahiko