Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer

Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer - SHARE study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030558

Enrollment

240

Registered

2018-02-01

Start date

2018-02-01

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

sentinel node biopsy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Physical function enough to receive chemotherapy. 2) Unilateral T1-3N1M0 breast cancer by image diagnosis. 3) Invasive cancer proven by histological examination. 4) Lymph node metastases proven with aspiration cytology or core needle biopsy. 5) ycN0 breast cancer after primary chemotherapy.

Exclusion criteria

Exclusion criteria: 1) Non-invasive cancer, or T4 and/or M1 breast cancer. 2) Clinical N0 or N2 and more metastases. 3) Women with pregnancy or breast-feeding. 4) Synchronous bilateral breast cancer 5) Cases with other invasive disease during treatment.

Design outcomes

Primary

Measure	Time frame
false negative rate of sentinel node biopsy	—

Countries

Japan

Contacts

Public ContactSATOMI YANA

Japanese Society for Sentinel Node Navigation Surgery Office

yanas@z7.keio.jp03-3353-6440

Outcome results

None listed

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