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A prospective observational study on digital pathology and artificial intelligence-based prediction of treatment response to neoadjuvant therapy in breast cancer patients

A prospective observational study on digital pathology and artificial intelligence-based prediction of treatment response to neoadjuvant therapy in breast cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111225
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Breast Cancer

Interventions

HR+HER2-breast cancer group:None
HER2+ breast cancer group:None
Triple-negative breast cancer group:None

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Signed an informed consent. 2.Age >= 18 years. 3.Female. 4.Histologically confirmed diagnosis of unilateral invasive breast cancer. 5.Molecular subtype must be confirmed by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).

Exclusion criteria

Exclusion criteria: 1.Presence of distant metastases. 2.History of another malignant disease, except for appropriately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers from which the patient has been disease-free for over 5 years. 3.Prior antitumor therapy before participating in this study. 4.Did not receive curative breast cancer surgery following neoadjuvant therapy. 5.No pathological diagnosis was performed on the curative surgery specimen. 6.Immunodeficiency or HIV infection. 7.Severe impairment of cardiac, pulmonary, hepatic, or renal function. 8.Uncontrolled or active infection. 9.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response;

Secondary

MeasureTime frame
Miller-Payne Grading;Residual Cancer Burden Grading;Event-free Survival;Overall Survival;

Countries

China

Contacts

Public ContactZhimin Shao

Fudan University Shanghai Cancer Center

zhimin_shao@yeah.net+86 199 4623 4783

Outcome results

None listed

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