A Phase II randomised, double-blind, stratified, multi-centre trial comparing the Nolvadex 20 mg and placebo combination to the Nolvadex 20 mg and ZD1839 (IRESSA™) 250 mg combination in patients with ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2005-004548-30

A Phase II randomised, double-blind, stratified, multi-centre trial comparing the Nolvadex 20 mg and placebo combination to the Nolvadex 20 mg and ZD1839 (IRESSA™) 250 mg combination in patients with metastatic breast cancer and estrogen receptor (ER) and/or progesterone (PR) positive tumours

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Extrait

Strata 1 To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex ) Strata 2 To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)


Critère d'inclusion

  • Female patients aged ³18 years, pre/post menopausal with ER and/or PR positive metastatic adenocarcinoma of the breast determined by each laboratory in each centre. Patients will be stratified into 2 categories based on prior hormonal therapy: ·newly diagnosed metastatic disease or that completed adjuvant therapy with tamoxifen at least 1 year prior to starting this protocol ·recurrent disease during, or after adjuvant AI or failing first line treatment with AI for metastatic disease

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