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A Phase I/II randomised, double-blind, multi-centre study to assess the efficacy of AZD2281 when given in combination with paclitaxel in the 1st or 2nd line treatment of patients with metastatic Tripl...

Update Il y a 4 ans
Reference: EUCTR2008-002608-25

A Phase I/II randomised, double-blind, multi-centre study to assess the efficacy of AZD2281 when given in combination with paclitaxel in the 1st or 2nd line treatment of patients with metastatic Triple Negative Breast Cancer

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Extract

The primary objective of the Phase I part of this study is: · To establish the appropriate doses of paclitaxel and AZD2281 in combination, based on safety and tolerability (for use in the randomised Phase II part of the study). The primary objective of the Phase II part of this study is: · To determine the efficacy (assessed by Progression Free Survival [PFS]) of AZD2281 in combination with paclitaxel compared to paclitaxel alone in this patient population.

Inclusion criteria

  • Metastatic Triple Negative Breast Cancer

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