Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC with Perjeta and Docetaxel in Patients with HER2-positive Advanced Breast Cancer

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-001458-40

Femme Homme

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Extrait

The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2−positive advanced (metastatic or locally recurrent) breast cancer. • Overall safety profile as determined by adverse events of any grade of severity, and adverse events Grade ≥ 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 and cardiac function will be assessed including the following: cardiac events Grade ≥ 3, congestive heart failure (CHF), and cardiac death


Critère d'inclusion

  • HER2−POSITIVE METASTATIC OR LOCALLY RECURRENT ADVANCED BREAST CANCER