At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
TAK-228 +1 moredrug
Likely dose
Not stated in 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.
Open Label, Phase II Trial of Neoadjuvant TAK-228 Plus Tamoxifen in Patients With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating TAK-228 and Tamoxifen for Estrogen Receptor Positive Breast Cancer. Completed, enrolled 28 participants across 3 sites.
Detailed Summary
This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Positive Breast Cancer
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartApr 2017
Primary CompletionFeb 2019
Study CompletionMar 2019
TodayJul 2026
First PostedDec 12, 2016
Enrollment StartApr 24, 2017
Primary CompletionFeb 1, 2019
Study CompletionMar 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.6 years ago
Interventions
TAK-228drug
MTORC1/2 inhibitor
Tamoxifendrug
Non-steroidal anti-estrogen