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Application of Novel Molecular and Imaging Predictive Tools in Neoadjuvant Immunotherapy for Resectable Triple-Negative Breast Cancer: A Prospective Observational Clinical Study

Application of Novel Molecular and Imaging Predictive Tools in Neoadjuvant Immunotherapy for Resectable Triple-Negative Breast Cancer: A Prospective Observational Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113558
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

breast cancer

Interventions

Observation group:none

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Females, aged 18-75 years, with an ECOG performance status of 0-1; 2. Pathologically confirmed TNBC (ER < 1%, PR < 1%, HER2 IHC 0-2+, excluding HER2 ISH+); 3. Breast cancer stage T1-3N0-1M0; 4. Receiving neoadjuvant immunotherapy combined with chemotherapy, where immunotherapy includes PD-1 or PD-L1 monoclonal antibodies.

Exclusion criteria

Exclusion criteria: 1. Insufficient neoadjuvant immunotherapy of fewer than 4 treatment cycles due to various reasons; 2. Malignant tumors originating from other organs that have metastasized to the breast, or presence of other unresolved malignant tumors; 3. Pregnancy-associated breast cancer; 4. Lack of pathological complete response data during follow-up; 5. Insufficient or inaccessible samples required for ImPredict score/IPPI model assessment.

Design outcomes

Primary

MeasureTime frame
Area under the curve for pathological complete response;

Secondary

MeasureTime frame
distant recurrence-free survival;

Countries

China

Contacts

Public ContactZongchao Gou

West China Hospital, Sichuan University

fdchao@126.com+86 28 8542 2953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026