Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components

Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components - Phase II study on radiofrequency ablation in stage 0 and I breast cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013836

Enrollment

Registered

2014-04-30

Start date

2012-12-01

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

thermal ablation of RFA in breast cancer

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Written informed consent is obtained. 2. Histologically invasive or noninvasive breast cancer. 3. stage 0 (TisN0M0) or I (T1N0M0 or T1N1miM0). 4. pN0(sn) or pN1mi(sn). 5. Image diagnosis of mammogram, ultrasound, and MR mammogram satisfies the following conditions: tumor with 2cm or less in diameter including extensive intraductal components, tumor not near the nipple-areolar complex, no skin retraction above the tumor, no multifocality, and/or limited microcalcification of the tumor.

Exclusion criteria

Exclusion criteria: male breast cancer. bilateral breast cancer. pregnant women or case with lactating breast. special type of breast cancer, e.g. lobular carcinoma.

Design outcomes

Primary

Measure	Time frame
pathological complete ablation rate	—

Secondary

Measure	Time frame
safety of RFA procedure, cosmetic outcome after RFA, 10-year relapse-free survival, 10-year overall survival	—

Countries

Japan

Contacts

Public ContactShigeru Imoto

School of Medicine Kyorin University Department of Breast Surgery

imoto@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

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