Trial intelligence / Profile preview

GDC-9545 + palbociclib versus anastrozole + palbociclib in neoadjuvant ER-positive/HER2-negative early breast cancer

2020-001007-16Phase 2Completed

Sponsor
Roche
Start
Sep 2020
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Irreversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Small Molecules
Countries
1
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Overview

Phase 2, randomised, open-label trial in breast cancer and Estrogen receptor-positive HER2-negative breast cancer (ER+/HER2-) comparing GDC-9545 plus palbociclib with Anastrozole plus palbociclib (2 arms). Primary endpoint: Central assessment of changes in Ki67 scores from baseline to Week 2. Started Sep 2020; status: completed.

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Drugs

giredestrantanastrozolepalbociclib
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Conditions

breast cancerEstrogen receptor-positive HER2-negative breast cancer (ER+/HER2-)

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