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 December 21, 2024

Recruiting

Keywords

Triple Positive Breast Cancer Dalsillie Pyrrolizinib

ClinConnect Summary

This clinical trial is studying a combination treatment for elderly women with advanced triple-positive breast cancer (TPBC). The treatment includes a medication called Darcilil, which is designed to work alongside another drug called Pyrrotinib and an aromatase inhibitor (AI). This study is important because older patients often struggle with traditional chemotherapy, and researchers want to find effective treatment options that are easier for them to tolerate. The goal is to see how well this new combination works and if it can improve outcomes for these patients.

To be eligible for this trial, participants must be women aged 65 and older with a confirmed diagnosis of stage IV TPBC. They should not have received any treatment for their cancer in the past year and must meet certain health criteria, such as having normal blood counts and organ function. If enrolled, participants will receive the treatment until their disease worsens, they experience unacceptable side effects, or they choose to withdraw from the study. The trial aims to provide hope for better treatment options for elderly women facing this challenging condition.

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