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New title: Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimens with 3 doses of ZK 219477 (16 and 12 mg...

Mise à jour : Il y a 5 ans
Référence : EUCTR2005-003216-30

New title: Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimens with 3 doses of ZK 219477 (16 and 12 mg/m² body surface area as 3-hour infusion or 22 mg/m² body surface area as 30-minute or 3-hour infusion) in patients with metastatic breast cancer. (Old title before amendment:Prospective, multicenter, randomized, parallel-group, open-label phase II study to investigate the efficacy, safety and tolerability of 2 doses of ZK 219477 (16 and 12 mg/m² body surface area) in patients with metastatic breast cancer.)

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Extrait

To investigate the efficacy of 4 regimens with 3 doses of ZK 219477 in patients with metastatic breast cancer in progression following a maximum of 2 previous regimen of chemotherapy. Previous chemotherapy must not include taxanes or vinca alkaloids.

Critère d'inclusion

  • Histologically proven metastatic breast cancer

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