A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

PRODUCTOS ROCHE Q.F.S.A.,0 个研究点目标入组 9 人开始时间: 2008年12月5日最近更新: 2023年9月4日

适应症

试验速览

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•Women with locally advanced, inflammatory or early, unilateral and invasive breast cancer histologically confirmed.
•Primary tumor> 2 cm in diameter.
•HER2 positive breast cancer confirmed by the central laboratory. The tumors must be HER2 + 4- + in IHC or FISH / CISH + (FISH / CISH is mandatory in HER2 ++ tumors).
•Availability of FFPE tissue for confirmation of the status of HER2 in the central laboratory (the FFPE tumor tissue will be used later to assess the status of biomarkers).
•Age> 18 years.
•Baseline LVEF> 55% (valued in echocardiography or MUGA).
•ECOG functional status • If the patient has undergone a major surgery intervention unrelated to the study, a minimum of 4 weeks must have elapsed and she must have fully recovered.

•metastatic disease (Stage IV) or bilateral breast cancer;
•previous anticancer therapy or radiotherapy for any malignancy;
•other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
•insulin-dependent diabetes;
•clinically relevant cardiovascular disease.

发起方

PRODUCTOS ROCHE Q.F.S.A.,