Treatment for elderly patients with advanced triple-positive breast cancer
Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of Elderly Advanced Triple-positive Breast Cancer.
This study is testing a new combination treatment for elderly patients with advanced triple-positive breast cancer to see if it is safe and effective for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Second Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | Pyrrotinib, chemotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06235931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older with histologically confirmed stage IV triple-positive breast cancer who have not received prior treatment for their condition.
Not a fit: Patients with early-stage breast cancer or those who have received prior anti-HER2 therapy within the last year may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more tolerable and effective option for elderly patients with advanced triple-positive breast cancer.
How similar studies have performed: While there have been studies on treatments for advanced breast cancer, this specific combination approach in elderly patients with triple-positive breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Hui Wang
- Email: whuisd@163.com
- Phone: 13913501391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.