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Clinical Trial 20152
Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03997123
Phase: Phase III
Prinicipal Investigator: Aixa Soyano Muller
Study Title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC)
Summary
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC)
Objective
To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS. To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by assessment of OS. Secondary: To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS. To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS2.
Therapies
Medications
Capivasertib (); Placebo (); Taxol (paclitaxel); paclitaxel ()
Inclusion Criteria:
Exclusion Criteria:
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