Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo total mastectomy

Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo total mastectomy - Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo total mastectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036897

Enrollment

180

Registered

2019-07-01

Start date

2019-05-30

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with one sentinel-node macro-metastasis who undergo total mastectomy

Interventions

omission of axillary dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) primary breast cancer 2) Tis,T1,T2 N0M0 3) total mastectomy 4) 20 years old or older 5) Performance status(ECOCG) 0 or 1 6) preserved the function of main organs 7) obtain consent of the patient to participate in the study

Exclusion criteria

Exclusion criteria: 1) ipsilateral breast tumor recurrence 2) primary systemic therapy 3) extracapsular invasion of lymph node 4) pregnancy or lactation stage 5) no systemic therapy after surgery 6) inaapropirate for participation

Design outcomes

Primary

Measure	Time frame
5-year distant disease-free survival rate	—

Countries

Japan

Contacts

Public ContactUta Nakadaira

Cancer Institute Hospital, Japanese Foundation for Cancer Research Department of Breast Surgical Oncology, Breast Oncology Center

uta.nakadaira@jfcr.or.jp0335200111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026