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Application of Novel Molecular and Imaging Predictive Tools in Immunotherapy for Untreated Locally Advanced or Metastatic Triple-Negative Breast Cancer: A Prospective Observational Clinical Study

Application of Novel Molecular and Imaging Predictive Tools in Immunotherapy for Untreated Locally Advanced or Metastatic Triple-Negative Breast Cancer: A Prospective Observational Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113577
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

Untreated Locally Advanced or Metastatic Triple-Negative Breast Cancer:None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Females, aged 18-75 years, with an ECOG performance status of 0-1; 2. Pathologically confirmed TNBC in the primary breast tumor (ER 6 months, c. At least one measurable lesion; 4. Receiving 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 PFS data during follow-up; 5. Insufficient or inaccessible samples required for ImPredict score/IPPI model assessment; 6. Presence of brain metastases at enrollment.

Design outcomes

Primary

MeasureTime frame
Predictive Performance of progress-free Survival;

Secondary

MeasureTime frame
Overall 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