At a glance
ClinicalIndex Comparison RecordPhase 3Active· 250 enrolled
Drug / intervention
Ipatasertib +2 moredrug
Likely dose
Ipatasertib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
In Brief
A Phase 3 clinical trial evaluating Ipatasertib, Fulvestrant, and 1 other intervention for Breast Cancer. Active but no longer recruiting, targeting 250 participants across 39 sites in 3 countries.
Detailed Summary
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Canada, New Zealand
CollaboratorsHoffmann-La Roche
Timeline
Phase 3Active
2021202220232024202520262027
First PostedDec 2020
Enrollment StartJan 2021
Primary CompletionMay 2025
TodayJul 2026
Study CompletionDec 2026
First PostedDec 2, 2020
Enrollment StartJan 27, 2021
Primary CompletionMay 23, 2025
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.6 years ago
Interventions
Ipatasertibdrug
400 mg PO QD days 1-21 every 28 days
Fulvestrantdrug
500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
Placeboother
PO QD days 1-21 every 28 days