Pyrotinib at Different Doses in Combination With Trastuzumab and Paclitaxel Chemotherapy for First-Line Treatment of HER2-Positive Advanced Breast Cancer: A Multicenter, Randomized, Double-Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The subjects voluntarily joins the study and signs the informed consent;

• Subject is an adult female or male ≥ 18 years old and ≤ 75 years old at the time of informed consent;

• HER2-positive advanced breast cancer confirmed by pathology:HER2-positive was defined as \>10% of immunoreactive cells with an immunohistochemical (IHC) score of 3+ or HER2 gene amplification as a result of in situ hybridization (ISH). HER2 positivity should be verified by the pathology department of the research center;

• Recurrent or metastatic breast cancer; Patients with local recurrence had to be confirmed by the investigator as not amenable to curative resection;

• At least one measurable lesion or only bone metastases according to RECIST v1.1 criteria (including osteolytic lesions or mixed osteolytic/osteoblastic lesions);

• When randomized, Eastern Cooperative Oncology Group(ECGO) physical fitness status is 0 or 1 point;

• Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors during screening) : Absolute neutrophil (ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥9g/dL; Total Bilirubin(TBIL) ≤ULN((Known patients with Gilbert's syndrome:Total Bilirubin(TBIL) ≤2×ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN(Patients with liver metastasis:ALT and AST≤5×ULN); Alkaline phosphatase (AKP) ≤ 2.5 times ULN; Blood Urea Nitrogen and Serum creatinine (Cr) ≤1.5×ULN;Left Ventricular Ejection Fractions(LVEF)≥50%;Corrected QT Interval(QTcF)\<470msec.

Locations
Other Locations
China
Jiangsu Provincial People's Hospital
RECRUITING
Nanjing
Contact Information
Primary
Yongmei Yin, Ph.D
ymyin@njmu.edu.cn
025-68307102
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 200
Treatments
Experimental: Pyrotinib low dose group
Pyrotinib: 320mg , peros(po) , once a day(qd) , every 3 weeks(q3w)
Active_comparator: Pyrotinib normal dose group
Pyrotinib: 400mg , peros(po) , once a day(qd) , every 3 weeks(q3w)
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Affiliated Hospital of Jiangsu University, Affiliated Hospital of Nantong University, The Affiliated Hospital of Xuzhou Medical University, The Second People's Hospital of Changshu, The First People's Hospital of Xuzhou, Shuyang County Traditional Chinese Medicine Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov