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Establish an immune scoring system for Node-PCR prediction and prognosis of cN + breast cancer patients after neoadjuvant therapy

Breast cancer neoadjuvant efficacy and prognosis prediction experiment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070356
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Breast cancer

Interventions

Sponsors

Sichuan Cancer Hosipital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ( 1 ) Women ; ( 2 ) aged 18 to 70 ; ( 3 ) Breast has measurable and evaluable lesions ; ( 4 ) Breast lesions before treatment core needle biopsy, histopathological diagnosis of invasive breast cancer ; ( 5 ) Fine needle or thick needle puncture confirmed ipsilateral axillary lymph node metastasis ; ( 6 ) Clinical examination except distant metastasis ; ( 7 ) did not receive chemotherapy, endocrine therapy or local radiotherapy and other malignant tumor related treatment before treatment ; ( 8 ) No other malignant tumor ; ( 9 ) Complete the established neoadjuvant therapy containing anthracycline and / or taxane chemotherapy drugs, if combined with targeted therapy to complete all courses according to treatment standards ; ( 10 ) underwent radical mastectomy after neoadjuvant therapy ; ( 11 ) Enough tumor tissue samples for standardized evaluation of total sTILs and dominant subgroups of sTILs ; ( 12 ) Complete clinicopathological and follow-up data.

Exclusion criteria

Exclusion criteria: ( 1 ) Males ; ( 2 ) 70 years of age ; ( 3 ) Occult breast cancer ; ( 4 ) Preoperative evaluation of axillary lymph node negative or uncertain ; ( 5 ) with distant metastasis ; ( 6 ) received chemotherapy, endocrine therapy or local radiotherapy and other malignant tumor related treatment before treatment ; ( 7 ) with other parts of the malignant tumor ; ( 8 ) Receiving neoadjuvant therapy without anthracycline and / or taxane chemotherapy drugs, failing to complete the established neoadjuvant therapy, and failing to complete all courses of targeted therapy ; ( 9 ) Dose intensity and / or efficacy evaluation of therapeutic drugs affected by concomitant diseases ; ( 10 ) No radical surgery for breast cancer was performed after neoadjuvant therapy ; ( 11 ) Breast cancer during lactation and pregnancy ; ( 12 ) Tumor tissue samples could not be used for standardized evaluation of total sTILs and sTILs advantage subgroups ; ( 13 ) Clinical, pathological, imaging and follow-up data were incomplete.

Design outcomes

Primary

MeasureTime frame
tumor-infiltrating lymphocytes;

Secondary

MeasureTime frame
Positive axillary lymph nodes on ultrasound and MRI images;

Countries

China

Contacts

Public ContactExian Mou

Sichuan Cancer Hosipital

785203071@qq.com+86 18583671536

Outcome results

None listed

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