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Predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy

Predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy - JBCRG-04(CREATE-X) TR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040260
Enrollment
606
Registered
2020-04-28
Start date
2020-06-01
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

None listed

Sponsors

Japan Breast Cancer Research Group (JBCRG)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who were registered A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy (JBCRG-04) trial

Exclusion criteria

Exclusion criteria: This study is a retrospective observational study, carried out by the opt-out method of our website.

Design outcomes

Primary

MeasureTime frame
Correlation between tumor immune microenvironment and 1)-6) 1) Patient characteristics, Pathological signature such as ER, HER2 status. 2) Disease free survival 3) Overall survival 4) Incidence of local recurrence 5) Incidence of distant metastasis 6) Clinical response rate of neoadjuvant chemotherapy

Countries

Japan

Contacts

Public ContactKosuke Kawaguchi

Kyoto University Graduate School of Medicine Department of breast surgery

kkosuke@kuhp.kyoto-u.ac.jp075-751-3660

Outcome results

None listed

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