Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy

Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy - CNB for Breast Cancer Acquired cCR with NAC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012035

Enrollment

Registered

2013-10-15

Start date

2013-10-15

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

Invasive Breast Cancer

Interventions

Core needle biopsy is performed just before resection of the primary lesion under general anesthegia for the resection procedure.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Woman age of 20 to 75 years old at registration. 2) Invasive breast cancer proven by core biopsy. 3) Negative for estrogen receptor immunohistochemically. 4) No prior therapy including radiation, endocrine therapy or immunotherapy except for neoadjuvant chemotherapy for existing breast cancer. 5) Expected complete response for invasive cancer by neoadjuvant chemotherapy with imaging study. 6) Informed consent must be obtained before patient registration.

Exclusion criteria

Exclusion criteria: 1) Male gender 2) Judged to be inadequate by the doctor.

Design outcomes

Primary

Measure	Time frame
Accuracy of pCR with CNB	—

Secondary

Measure	Time frame
Accuracy of pCR with imaging study.	—

Countries

Japan

Contacts

Public ContactKazutaka Narui

Yokohama City University Medical Center Department of Breast and Thyroid Surgery

nr1@gc5.so-net.ne.jp045-261-5656

Outcome results

None listed

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