A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes

A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes - A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023435

Enrollment

189

Registered

2016-08-30

Start date

2016-08-01

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

to omit axillary dissection for patients with one to two positve sentinel lymph nodes

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) diagnosed as breast cancer by core needle/vacuum assisted biopsy 2)clinical N0 3)planned to undergo lumpectomy and radiation therapy 4)written informed consent

Exclusion criteria

Exclusion criteria: prior therapy T3,T4 M1

Design outcomes

Primary

Measure	Time frame
5year axillary recurrence rate	—

Secondary

Measure	Time frame
1)Overall survival 2)recurrence-free suvival 3)local recurrence-free suvival 4)the rate of upper-limb lymphedema 5)Quality of life 6)comparison of axillary recurrence rate between patients with two or more nodes dissected and only one positive node and those with other situation	—

Countries

Japan

Contacts

Public ContactAkira Hirano

Tokyo Women's Medical University, Medical Center East Department of Breast Surgery

ahirasu@dnh.twmu.ac.jp03-3810-1111

Outcome results

None listed

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