AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)

Phase 1 Active not recruiting 77 enrolled Massachusetts General Hospital Genentech, Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer.

Timeline

Start: 2019-05-30
Primary completion: 2022-12-25
Completion: 2026-07

Publications

Wander SA, Lloyd MR, Keenan JC, Scott EC, Niemierko A, Spring LM, Fell GG, Shin J, Isakoff SJ, Moy B, Ryan L, Padden S, Fisher E, Newton A, Habin KR, Viscosi-Spieler ET, Scarpetti L, Varkaris A, Ellisen LW, Dubash T, Che D, Patel PS, de la Cruz FF, Sutaria DS, Sane RS, Micalizzi DS, Maheswaran S, Haber DA, Juric D, Bardia A. Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial. Lancet Oncol. 2026 May;27(5):580-591. doi: 10.1016/S1470-2045(26)00059-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	Exemestane	Small molecule	25 mg	Oral
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Ipatasertib	Small molecule	200 mg	Oral
Subject	Ipatasertib	Small molecule	400 mg	Oral
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Palbociclib	Small molecule	100 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral

AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)

Summary

Timeline

Publications

Drugs

Indications