NCT03959891

Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor, Ipatasertib,With Endocrine Therapy With/Without CDK 4/6 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer (TAKTIC)

Active, enrolled Phase 1 Last updated 25 September 2025

What this trial tests

Phase 1 trial testing Ipatasertib in Breast Cancer in 77 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 May 2019

Primary endpoint
25 December 2022

1 July 2026

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	77
Start date	30 May 2019
Primary completion	25 December 2022
Estimated completion	1 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Ipatasertib
• Fulvestrant (fulvestrant) — full drug profile →
• Aromatase Inhibitor (aromatase-inhibitor) — full drug profile →
• Palbociclib (Palbociclib) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of Treatment-Emergent Adverse Events
  Time frame: 2 years
  grade 1-5 (CTCAE)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CDK4 and CDK6 kinases: From basic science to cancer therapy.
   Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
2. Breast Cancer Treatments: Updates and New Challenges.
   Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
3. AKT Inhibitors: New Weapons in the Fight Against Breast Cancer?
   Martorana F, Motta G, Pavone G, Motta L, et al · · 2021 · cited 154× · PMID 33995085 · DOI 10.3389/fphar.2021.662232
4. Endocrine resistance in breast cancer: from molecular mechanisms to therapeutic strategies.
   Saatci O, Huynh-Dam KT, Sahin O. · · 2021 · cited 110× · PMID 34623477 · DOI 10.1007/s00109-021-02136-5
5. Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy.
   Sirico M, D'Angelo A, Gianni C, Casadei C, et al · · 2023 · cited 76× · PMID 36765661 · DOI 10.3390/cancers15030703
6. Mechanisms of Resistance to PI3K Inhibitors in Cancer: Adaptive Responses, Drug Tolerance and Cellular Plasticity.
   Wright SCE, Vasilevski N, Serra V, Rodon J, et al · · 2021 · cited 71× · PMID 33810522 · DOI 10.3390/cancers13071538
7. Targeting PI3K/AKT/mTOR Pathway in Breast Cancer: From Biology to Clinical Challenges.
   Cerma K, Piacentini F, Moscetti L, Barbolini M, et al · · 2023 · cited 64× · PMID 36672617 · DOI 10.3390/biomedicines11010109
8. Clinical Development of AKT Inhibitors and Associated Predictive Biomarkers to Guide Patient Treatment in Cancer Medicine.
   Coleman N, Moyers JT, Harbery A, Vivanco I, et al · · 2021 · cited 46× · PMID 34858045 · DOI 10.2147/pgpm.s305068