A phase 3 randomized, double-blind study of PF-05280014 plus paclitaxel versus trastuzumab plus paclitaxel for the first-line treatment of patients with HER2-positive metastatic breast cancer - RACE

Pfizer Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Female patients aged 18 years or older.
•Histologically confirmed diagnosis of breast cancer.
•Presence of metastatic disease.
•Prior documentation of HER2 gene amplification or overexpression. Determination of HER2 positive status using one of the Sponsor accepted analytical test.
•Available tumor tissue for central review of HER2 status.
•At least 1 measurable lesion as defined by RECIST 1.1.
•Eastern Cooperative Oncology Group status of 0 to 2.
•Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.

•Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment.
•Prior systemic therapy for metastatic disease (except endocrine therapy).
•Prior cumulative dose of doxorubicin of more than 400 mg per m2, epirubicin dose more than 800 mg per m2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mgper m2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg per m2 of doxorubicin.
•Inflammatory breast cancer.
•Active uncontrolled or symptomatic central nervous system metastases.

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