TAD after NAC for node-positive breast cancer

JRCT ID: jRCT1032210236

Registered date:12/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: node-positive primary breast cancer at dianosis who receive neoadjuvant chemotherapy
• Date of first enrollment: 12/08/2021
• Target sample size: 112
• Study type: Interventional
• Intervention(s): removal of at least 3 clipped nodes and sentinel nodes

Outcome(s)

• Primary Outcome: 3 year locoregional recurrence-free survival

Secondary Outcome

negative predictive value of node negative,
3 year regional recurrence-free survival,
3 year distant disease-free survival,
Complication rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Estrogen receptor negative invasive ductal carcinoma
2. Axillary lymphnode metastasis confirmed by biopsy or cytology at diagnosis
3. Upto 3 axillary lymphnode metastases on ultrasound or CT at diagnosis
4. A clinical T1 or T2 invasive ductal carcinoma
5. Candidate for anthracycline and taxane-based neoadjuvant chemotherapy
6. 20 year or older
7. Written patient Informed consent
8. Performance status: ECOG 0 -1
9. Maintained organ function

Exclude criteria

1. Stage IV disease with distant metastasis
2. Pregnancy
3. Inflammatory breast cancer
4. Invasive lobular or invasive micropapillary carcinoma
5.bilateral breast cancer
6. Metal allergy
7. Prior history of axillary surgery or radiation therapy on axillary field
8. Active infection disease
9. Inability to join the study due to mental status
10. BMI: Body mass index 35 or higher
11. Other conditions regarded as intoleratable for the study

Related Information

• Primary Sponsor: Hayashi Naoki
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research C