A Phase 4 interventional study of letrozole in Locally Advanced Breast Cancer and Hormone Receptor Positive,HER2-negative Breast Cancer, sponsored by Yongsheng Wang. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Yongsheng Wang · Phase 4, Interventional, and Treatment
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Yongsheng Wang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Breast cancer following:
Histologically confirmed invasive breast cancer with primary tumor diameter >2 cm by standard evaluation methods.Tumor stage: cT2-cT4/cN0-cN3/cM0 (clinical phase II and III)
Major organ function following:
Complete blood count: Neutrophil (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 90×109/L; hemoglobin (Hb) ≥90 g/L; Blood Biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) ≤ 1.5×ULN; Aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Urea nitrogen (BUN) ≤ 1.5×ULN; Creatinine (Cr) ≤ 1.5×ULN; Twelve-lead electrocardiogram: Fridericia corrected QT Interval (QTcF) woman \< 470 ms (QTcF=QT/(RR\^1/3));
Exclusion Criteria:
Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy,if ki67 was higher than 10% after two weeks,CDK4/6 Inhibitor was added.
Drug: letrozole
Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy,if don't work, CDK4/6 Inhibitor was added.
Also known as: CDK4/6 Inhibitor
ki67 index
Independent review committee (IRC) evaluates the Ki67 index after treatment. Ki67 index using the definition of HE stained breast cancer samples after neoadjuvant therapy and surgery. (Defined by the American Joint Committee onCancer, AJCC).
Time frame: Up to approximately 2 weeks
Objective Overall Response Rate
Defined as the proportion of subjects who achieved CR or PR as optimal tumor response during neoadjuvant therapy. Objective response rates will be assessed according to the RECIST v1.1 for the evaluation of efficacy in solid tumors.
Time frame: Up to approximately 7 weeks
Plan to share: No
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Yongsheng Wang