A prospective interventional study to evaluate the validity of sentinel node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis

A prospective interventional study to evaluate the validity of sentinel node biopsy for omitting axillary dissection after neoadjuvant chemotherapy for breast cancer patients with axillary lymph node metastasis - Ganken Breast center TAD study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048307

Enrollment

Registered

2022-07-28

Start date

2021-01-01

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

Interventions

TAD(sentinel node biopsy + cytologicaly confirmed lymph node biopsy) for the candidates who achieved clinical node negative (ycN0) after NAC Omit axillary dissection if intraoperative pathological di

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: cT1-3, cN1-3 (confirmed by aspiration cytology), M0(confirmed by PET-CT), primary breast cancer ycN0 diagnosed by axillary ultrasound ycN0 confirmed at a multidisciplinary conference

Exclusion criteria

Exclusion criteria: inflammatory breast cancer cases in which lymph node evaluation is difficult

Design outcomes

Primary

Measure	Time frame
Axillary recurrence rate after omitting axillary dissection	—

Secondary

Measure	Time frame
Identification rate of SLN and targeted LN, distant disease-free survival rate, overall survival rate, accuracy for imaging diagnosis, the incidence of lymphedema, and incidence of sensory impairment of the upper limbs	—

Countries

Japan

Contacts

Public ContactTakehiko Sakai

Cancer Institute Hospital of JFCR Breast Surgical Oncology, Breast Oncology center

takehiko.sakai@jfcr.or.jp0335200111

Outcome results

None listed

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