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Prospective Validation of a 10-miRNA Gene Assay in Predicting Neoadjuvant Chemotherapy pCR of Luminal Breast Cancer

Prospective Validation of a 10-miRNA Gene Assay in Predicting Neoadjuvant Chemotherapy pCR of Luminal Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17013651
Enrollment
Unknown
Registered
2017-12-03
Start date
2017-11-21
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

breast cancer

Interventions

Sponsors

Sun Yat-sen Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign the Informed Consent Form; 2. Pathologically diagnosed non-metastasis breast cancer,TNM stage II or above; 3. Pathologically diagnosed Luminal breast cancer by core needle biopsy; 4. Didn't receive chemotherapy,endocrinotherapy,breast cancer related surgery or radiotherapy historically; 5. UCG shows normal EF value; 6. ECGO scoring less than 2; 7. Suitable for chemotherapy.

Exclusion criteria

Exclusion criteria: 1. With other malignant apart from breast cancer, but skin basal cell carcinoma and carcinoma in situ of uterine cervix are excluded; 2. With active infection which is inappropriate for chemotherapy; 3. With other sever disease which is inappropriate for chemotherapy; 4. With mental illness which could not understand the Informed Consent Form; 5. With sever cardio dysfunction; 6. With sever liver dysfunction, ChildPugh C; 7. With sever renal dysfunction.

Design outcomes

Primary

MeasureTime frame
pCR;10-miRNA RS;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
RCB;Rate of breast conserving surgery;Adverse Event;the relationship between other biomarkers from blood and pCR;

Countries

China

Contacts

Public ContactChang Gong

Sun Yat-sen Memorial Hospital

changgong282@163.com+86 13925089353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026