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TAD after NAC for node-positive breast cancer

Less invasive axillary surgery after neoadjuvant chemotherapy for node-positive primary breast cancer : A multicenter prospective study - Less invasive axillary surgery after neoadjuvant chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032210236
Enrollment
112
Registered
2021-08-12
Start date
2021-08-12
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

node-positive primary breast cancer at dianosis who receive neoadjuvant chemotherapy Breast Neoplasm

Interventions

removal of at least 3 clipped nodes and sentinel nodes
Minimally Invasive Surgical Procedures

Sponsors

Hayashi Naoki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
3 year locoregional recurrence-free survival

Secondary

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

Contacts

Public ContactNaoki Hayashi

St. Luke's International University, St. Luke's International Hospital

naokiha@luke.ac.jp+81-3-3541-5151

Outcome results

None listed

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