A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC

In this open design, single-arm, single-center, prospective clinical study, 28 elderly patients with triple-positive advanced breast cancer were planned to receive treatment with darcilil combined with pyrrotinib and AI until the disease progressed, toxicity became intolerable, informed consent was withdrawn, or the investigator judged that the drug must be discontinued. The main objective of this study was to observe the safety and efficacy of Dalcilil combined with pyrrotinib and AI in the treatment of triple-positive senile advanced breast cancer.

In this study, the screening period did not exceed 28 days, and qualified subjects entered the study treatment period (every 28 days is a treatment cycle) after completing the screening examination and evaluation, and conducted the study treatment and visit according to the protocol. Imaging evaluation was performed according to the clinical routine during the study treatment. The imaging evaluation could be carried out according to the RECIST 1.1 standard, and the evaluation result of the investigator was the final result. At the end of treatment/withdrawal from the study, subjects should visit the research center to complete the corresponding safety check and imaging evaluation; In addition, a visit to the research center was conducted 28 days after the last treatment to complete the corresponding safety assessment.

Safety follow-up: the subjects were followed up until the initiation of other antineoplastic drugs. All AE recovered to grade 0-1 or baseline levels or died, whichever was achieved first.

Efficacy follow-up: All subjects were required to be followed until tumor progression or death or withdrawal of informed consent, whichever came first.

Follow-up for survival: All subjects were followed for survival until death or withdrawal of informed consent or the end of the trial, whichever came first.

Inclusion criteria

• 1.Age: ≥65 years old; 2. Histologically confirmed stage IV TPBC; 3. Without prior treatment, adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year; 4.TPBC is defined as HER2-positive (3+ by immunohistochemistry, or 2+ by fluorescence in situ hybridization), ER-positive (more than 10% of tumor cells expressed estrogen receptor by immunohistochemistry), and PR-positive (at least 1% of tumor cells expressed progesterone receptor by immunohistochemistry) breast cancer; 5.ECOG score is 0-3 points; 6. Expected survival ≥12 weeks; 7. Normal function of major organs:

• Blood routine:

Neutrophil (ANC) ≥1.5×109/L; Platelet count (PLT) ≥75×109/L; Hemoglobin (Hb) ≥90 g/L;

• Blood biochemistry:

Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN; Alkaline phosphatase ≤2.5×ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;

• Heart color ultrasound:

Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion criteria

• 1. Breast cancer with no evaluable lesions such as inflammation or occult; 2. Other malignancies within five years 3. Received other tyrosine kinase inhibitors, anti-HER2 treatment and T-DM1 treatment less than one year ago; 4. Patients with intestinal obstruction or fasting, gastrointestinal history, with diarrhea as the main symptom; 5. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 6. Pregnant or lactating women; 7. Participants considered unsuitable for inclusion by the researchers.