A Phase II trial evaluating the immunological and clinical efficacy and safety of HER-2 Protein AutoVac(TM) and Stimulon® Adjuvant QS-21 monotherapy in patients with metastatic breast cancer

Update Il y a 4 ans
Reference: EUCTR2005-000558-60

Woman Man

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Extract

The primary objective of the trial is to demonstrate evidence of clinical efficacy of HER-2 Protein AutoVac(TM)/QS-21, that is the number of evaluable patients with evidence of clinical benefit, defined as: • A complete response (CR) or partial response (PR), or • Stable disease (SD) for at least 6 months (26 weeks).


Inclusion criteria

  • Female patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion

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