Actively Recruiting

Phase Not Applicable
Age: 65Years +
FEMALE
NCT06235931

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

Led by Second Affiliated Hospital of Soochow University · Updated on 2024-02-01

34

Participants Needed

1

Research Sites

147 weeks

Total Duration

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AI-Summary

What this Trial Is About

Elderly patients with advanced triple-positive breast cancer have the characteristics of low physical status and poor treatment tolerance. Therefore, such patients are often unable to tolerate more toxic chemotherapy regimen, and it is particularly important to choose a highly effective and low-toxic treatment regimen. However, few studies have paid attention to the treatment of such patients in the past. Pyrrotinib is a small molecule, irreversible, panerbb receptor tyrosine kinase inhibitor, which was independently developed by our country and has shown excellent efficacy in second-line anti-HER2 treatment of breast cancer, and has become the second-line standard treatment choice for advanced HER2-positive breast cancer. In addition, PHILA study results showed that the mPFS of pyrrotinib group reached 24 months. Compared with the control group, the duration of 10 months was significantly extended, indicating the significant efficacy of pyrrotinib in the first-line treatment of advanced HER2-positive breast cancer. Darsili is a CDK4/6 inhibitor independently developed in China, which has been reconstructed and optimized in molecular structure, and has become a new CDK4/6 inhibitor with more powerful modification by introducing piperidine structure through replacement of classical electronic and other panbody. The results of DAWNA-2 study indicated that the mPFS of Dalsily combined AI group reached 30.6 months, which was significantly longer than 18.2 months of the control group, and was the longest in similar studies. MUKDEN01 study, for the first time, tried the efficacy of pyrrotinib + letrozole + Dalsily regimen in the new adjuvant therapy of TPBC patients, and the results showed that ORR reached 87.4%, CR rate was 30.4%, and pCR rate was 35.4%. Therefore, to further confirm the efficacy and safety of this protocol in elderly patients with advanced triple positive breast cancer, we intend to conduct this study. This is a prospective, single-arm, single-center clinical trial in which participants were treated with darcilide +AI (letrozole/anastrozole/exemestane) + pyrrotinib until disease progression, toxicity became intolerable, informed consent was withdrawn, or investigator judgment required discontinuation. The successful development of this study provides a new direction for the first-line treatment of elderly advanced triple-positive breast cancer.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Histologically confirmed stage IV triple-positive breast cancer
  • No prior treatment; adjuvant endocrine therapy and anti-HER2 therapy completed over one year ago
  • Triple-positive breast cancer defined as HER2-positive (3+ by IHC or 2+ by FISH), ER-positive (>10% tumor cells), and PR-positive (≥1% tumor cells)
  • ECOG performance status 0 to 3
  • Expected survival of at least 12 weeks
  • Normal major organ function including:
    • Neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥90 g/L
    • Total bilirubin ≤1.5× upper limit of normal, ALT and AST ≤3.0× ULN, alkaline phosphatase ≤2.5× ULN, BUN and creatinine ≤1.5× ULN
    • Left ventricular ejection fraction ≥50% by echocardiogram
Not Eligible

You will not qualify if you...

  • Breast cancer without evaluable lesions, such as inflammatory or occult types
  • Other malignancies diagnosed within the past five years
  • Tyrosine kinase inhibitors, anti-HER2 therapy, or T-DM1 treatment within the last year
  • History of intestinal obstruction or fasting, or current diarrhea as main symptom
  • Mental illness or psychotropic substance abuse preventing cooperation
  • Pregnancy or lactation
  • Considered unsuitable for study participation by the investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

H

Hui Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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