Search / Trial NCT06235931

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

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jan 31, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Triple Positive Breast Cancer Dalsillie Pyrrolizinib

Description

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combined with pyrrotinib and AI until the disease progressed, toxicity became intolerable, informed consent was withdrawn, or the investigator judged that the drug must be discontinued.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...

Gender

FEMALE

Eligibility criteria

  • 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:
  • 1. Blood routine:
  • Neutrophil (ANC) ≥1.5×109/L; Platelet count (PLT) ≥75×109/L; Hemoglobin (Hb) ≥90 g/L;
  • 2. 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;
  • 3. 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.

About Second Affiliated Hospital Of Soochow University

The Second Affiliated Hospital of Soochow University is a leading medical institution in China, renowned for its commitment to advanced healthcare and clinical research. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to facilitate innovative treatments and improve patient outcomes. With a multidisciplinary team of experienced clinicians and researchers, the institution aims to contribute to the global medical community by advancing evidence-based practices and fostering collaborations that enhance therapeutic options. Through rigorous trial management and adherence to ethical standards, the Second Affiliated Hospital is dedicated to enhancing the quality of care and driving medical advancements.

Locations

Suzhou, Jiangsu, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0