Skip to content

A multi-institutional retrospective cohort study on dynamics of HER2 expression from primary site to metastatic or recurrent site in breast cancer

A multi-institutional retrospective cohort study on dynamics of HER2 expression from primary site to metastatic or recurrent site in breast cancer - HER2 PRIME study(JFMC52-2401-N1)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057077
Enrollment
250
Registered
2025-02-20
Start date
2025-02-21
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

Brest Cancer

Interventions

None listed

Sponsors

Japanese Foundation for Multidisciplinary Treatment of Cancer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are at least 18 years of age or older at the time of diagnosis of invasive breast cancer. 2) Patients diagnosed with histologically invasive breast cancer on or after January 1, 2013. 3) Patients diagnosed with histologically local recurrence or metastatic recurrence by December 31, 2023 after initial surgery for primary breast cancer. 4) Subjects where at least one tissue sample from the primary site (specimen at initial diagnosis and/or surgical resection specimen) and at least one tissue sample from the metastatic or recurrent site (specimen from distant metastatic site and/or specimen from locoregional recurrent site) can be submitted.

Exclusion criteria

Exclusion criteria: "1) Patients with active multiple cancers at the time of diagnosis of invasive breast cancer 2) Patients judged by the principal investigator or subinvestigator to be inappropriate for this study"

Design outcomes

Primary

MeasureTime frame
1)HER2 scoring of tumor tissue samples 2)Percentage of HER2-expressing cell composition by staining pattern in tumor tissue samples 3)Changes in HER2 expression from the primary site to metastatic or recurrent site in tumor tissue samples from the same patient

Secondary

MeasureTime frame
1)Changes in HER2 expression based on the timing or site of tumor tissue sample collection 2)Clinicopathological factors 3)Overall survival 4)Histological and morphological characteristics 5)Gene profiling 6)Protein expression analysis

Countries

Japan

Contacts

Public ContactShigeru Imoto

Japanese Foundation for Multidisciplinary Treatment of Cancer Office

jfmc52@jfmc.or.jp03-5627-7594

Outcome results

None listed

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