Treatment for elderly patients with advanced triple-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study focuses on elderly patients aged 65 and older with advanced triple-positive breast cancer (TPBC) who often struggle with traditional chemotherapy due to low physical status and treatment tolerance. The study aims to evaluate the safety and efficacy of a combination treatment involving darcilil, pyrrotinib, and aromatase inhibitors (AI) in this patient population. Participants will receive treatment until disease progression, intolerable toxicity, or withdrawal of consent, with regular assessments and follow-ups to monitor safety and treatment response. The study is designed as a single-arm, single-center, prospective trial with a planned enrollment of 28 patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Hui Wang
• Email: whuisd@163.com
• Phone: 13913501391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.