CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Tak-228 & Tak-117 +1 moredrug
Likely dose
TAK-228 4 mg oral + TAK-117 200 mg, followed by nab paclitaxel 175-220 mg/m² + cisplatin 60-75 mg/m² for six cyclesAI-extracted
Key inclusion· 6
  • ✓Female patients 18 years or older
  • ✓Metastatic TNBC with prior standard anthracycline, cyclophosphamide, and taxane chemotherapy (or contraindication to doxorubicin)
  • ✓No more than 3 prior chemotherapy regimens for metastatic disease
  • ✓Androgen receptor-negative (less than 10% positive nuclei) on standard IHC
Key exclusion· 11
  • ✕Leptomeningeal disease that is symptomatic or cytology-proven
  • ✕Previous treatment with PI3K, AKT, dual PI3K/mTOR inhibitors, TORC1/2 inhibitors, or TORC1 inhibitors
  • ✕Manifestations of malabsorption due to prior GI surgery, GI disease, or enteric stomata
  • ✕History of ischemic myocardial event, ischemic cerebrovascular event, or serious cardiac arrhythmia within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193853
NCT03193853Phase 2Completed
CompareCT.gov

Phase II Clinical Trial of Treatment With TAK-228 and TAK-117 to Inhibit Homologous Recombination (HR) Followed by Cisplatin and Nab Paclitaxel in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer

Joyce O'Shaughnessy·interventional·Posted Jun 21, 2017·Updated Aug 7, 2023

In Brief

A Phase 2 clinical trial evaluating Tak-228 & Tak-117 and Cisplatin & Nab Paclitaxel for Triple Negative Breast Cancer. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab paclitaxel in patients with metastatic triple negative breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartJul 18, 2017
Primary CompletionMar 17, 2020
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago

Interventions

Tak-228 & Tak-117drug

Patients will receive 4mg oral TAK-228 and 200mg TAK-117 tablets until disease progression.

Cisplatin & Nab Paclitaxeldrug

following Tak-228 \& Tak-117 standard nab paclitaxel 175-220 mg/m2 plus cisplatin 60-75 mg/m2 infusion for six cycles. Patients who did not progress may continue nab paclitaxel under treating physicians discretion