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Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benef...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000568-28

Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefit Randomizovaná studie u postmenopauzálních žen s ER pozitivním/ HER2 negativním nádorem prsu ověřující přínos kombinované předoperační léčby GDC-0032 a Letrozolu

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Extrait

The primary objective of this study is to evaluate the efficacy of letrozole plus GDC-0032 versus letrozole plus placebo in women with ER+/HER2- early stage breast cancer, as measured by the following co-primary endpoints: •Tumor overall objective response rate (ORR) by centrally assessed breast magnetic resonance imaging (MRI) via modified Response Evaluation Criteria in Solid Tumors (RECIST) in all enrolled patients and PIK3CA MT patients •pCR rate in breast and axilla (ypT0/Tis ypN0) by local evaluation in all enrolled patients and PIK3CA MT patients

Critère d'inclusion

  • WOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCER

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