CTRI/2025/09/094678招募中3 期
A phase III, multicentre, randomized, open label, active controlled, parallel group, non-inferiority study of Pyrotinib plus Capecitabine compared with Lapatinib plus Capecitabine in patients with HER2-positive metastatic breast cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 16
- 主要终点
- To evaluate the efficacy of Pyrotinib plus Capecita-bine compared with Lapatinib plus Capecitabine in patients with HER2-positive metastatic breast cancer.
研究概览
简要总结
An open label, multicenter, randomized, phase 3 study (PHOEBE trial) revealed that Pyrotinib plus capecitabine significantly improved PFS (12.5 months vs 6.8 months, p<0.0001) when compared with lapatinib plus capecitabine in patients with metastatic breast cancer. Furthermore, in phase 3 PHENIX study, Pyrotinib plus capecitabine significantly prolonged PFS (11.1 months’ vs 4.1 months, p<0.001) compared with capecitabine monotherapy in patients with HER2+ local-relapsed or metastatic breast cancer, who had received trastuzumab and taxanes.
Thus, in order to compare the efficacy and safety of Pyrotinib plus capecitabine versus lapatinib plus capecitabine as treatment in subjects with HER2-positive metastatic breast cancer, a phase III, randomized, open label, active controlled, parallel-group, non-inferiority, multicenter study has been proposed in Indian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females aged equal to or more than 18 years.
- •Patients with histological or cytological confirmed HER2 positive advanced breast cancer who have been previously treated with more than or equal to 1 prior HER2 directed therapy for advanced disease and for whom the investigator has planned Lapatinib plus Capecitabine as the intended regimen.
- •Note, HER2 positive status will be assessed with 3 plus staining intensity by immune histochemistry or HER2 gene amplification by fluorescence in situ hybridisation indicating HER2 positivity.
- •A HER2 positive breast cancer confirmed by the pathology department of the participating study centre.
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.
- •ECOG physical performance 0 to 1
- •Subjects willing to comply with protocol requirements
- •Willing to provide written informed consent
- •Lab parameters should meet the following requirements: ANC, more than or equal to 1.5 x 109 per Liter, Platelet more than or equal to 90 x 109 per Liter, Hb more than or equal to 9.0 gm per dl, Total bilirubin more than or equal to 1.0 x upper limit of normal, ALT and AST more than or equal to 2 x ULN, patients with liver metastases, less than or equal to 5 x ULN, Creatinine less than or equal to 1 x ULN, creatinine clearance less than or equal to 50 mL per min, LVEF less than or equal to 50 percent.
- •Fridericia-corrected QT interval less than 450 msec for males and less than 470 msec for females
- •Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period.
- •For women who are not postmenopausal, postmenopausal defined as more than or equal to 12 months of Non therapy induced amenorrhea, or surgically sterile, absence of ovaries and or uterus agreement to remain abstinent or use single or combined non hormonal contraceptive methods that result in a failure rate of less than 1 percent per year during the treatment period and for at least 8 weeks after the last dose of study treatment b.
- •Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient.
- •Periodic abstinence e.g., calendar, ovulation, or post ovulation methods and withdrawal are not acceptable methods of contraception.
- •Examples of non hormonal contraceptive methods with a failure rate of less than 1 percent per year include tubal ligation, male sterilization, and certain non hormonal intrauterine devices.
- •Alternatively, two methods, e.g., two barrier methods such as a condom and a cervical cap, may be combined to achieve a failure rate of less than 1percent per year.
- •Barrier methods must always be supplemented with the use of a spermicide d.
- •For men, agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1 percent per year during the treatment period and for at least 1 week after the last dose of study treatment e.
排除标准
- •History of hypersensitivity or allergy to any of the study drugs or its components
- •Received radiotherapy, chemotherapy, surgery, major surgery for breast cancer, or molecular targeted therapy within 4 weeks prior to randomization, received endocrine therapy within 7 days prior to randomization.
- •History of other malignant tumors in the past 5 years, other than cured cervical carcinoma in situ, basal or squamous cell carcinoma of skin
- •Presence of central nervous system metastases, definitive diagnosis of brain tumor by cranial CT or MRI scan
- •Presence of Dihydropyrimidine Dehydrogenase deficiency
- •Any antitumor treatment after informed consent and before randomization
- •Previous or current treatment with any tyrosine kinase inhibitor, including lapatinib, neratinib, and pyrotinib, targeting HER2
- •Previous capecitabine treatment for metastatic disease or in the neoadjuvant or adjuvant setting within 6 months before randomisation
- •History of exposure to the following cumulative doses of anthracyclines.
- •Doxorubicin or doxorubicin liposome more than 360 mg per meter square Epirubicin more than 720 mg per meter square, Mitoxantrone more than 120 mg per meter square idarubicin more than 90 mg per meter square
- •Factors influencing the oral administration in affected patients e.g. dysphagia, chronic diarrhea, intestinal obstruction, etc.
- •Uncontrolled third space effusion, such as pleural fluid and ascites, by drainage or other clinical intervention
- •Known history of any immunodeficiency disease, acquired or congenital immunodeficiency disease, or history of organ transplantation
- •History or presence of interstitial lung disease and or pneumonitis
- •No radiologically confirmed disease progression during or after the most recent anti tumor treatment before enrollment, as assessed by the investigator
- •Subjects with significant cardiovascular history such as Congestive heart failure, myocardial infarction, angina pectoris, stroke or transient ischemic attack, arrhythmia, or any other within 6 months prior to randomisation
- •Subjects who used the concomitant drugs, enlisted in section 7.3 that interfere with liver P450 enzymes or Pgp within 5 half lives of the concomitant drugs prior to the pyrotinib administration
- •Subject having any medical condition or any significant laboratory finding, which in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Female subjects who are Pregnant or lactating
- •Subjects with history of drug or alcohol abuse
- •Subjects with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to randomisation
- •Known case of HIV, HBV or HCV.
结局指标
主要结局
To evaluate the efficacy of Pyrotinib plus Capecita-bine compared with Lapatinib plus Capecitabine in patients with HER2-positive metastatic breast cancer.
时间窗: To evaluate the efficacy of Pyrotinib plus Capecita-bine compared with Lapatinib plus Capecitabine in patients with HER2-positive metastatic breast cancer.
次要结局
- To evaluate the safety and tolerability of Pyrotinib plus Capecitabine compared with Lapatinib plus Capecitabine in patients with HER2-positive meta-static breast cancer.(1. Objective Response Rate (defined as the proportion of patients with the best response of complete response [CR] or partial response [PR] per RE-CIST 1.1 at 12 months)
研究者
Dr M Rajalakshmi
Syngene International Limited
研究点 (16)
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