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

NCT03959891 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ipatasertib

Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt.

DRUG

Fulvestrant

Hormone therapies work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell.

DRUG

Aromatase Inhibitor

Letrozole is an aromatase inhibitor. This means it blocks the enzyme aromatase (found in the body's muscle, skin, breast and fat), which is used to convert androgens (hormones produced by the adrenal glands) into estrogen. In the absence of estrogen, tumors dependent on this hormone for growth will shrink.

DRUG

Palbociclib

Palbociclib (Ibrance®) is a drug that can be used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer. Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor. The drug blocks proteins in the cell called cyclin-dependent kinase (CDK) 4 and CDK 6. In hormone positive breast cancer cells, blocking these proteins helps stop the cells from dividing to make new cells. It helps prevent the cells from moving from G1 to S cell cycle phase in the division process. This slows cancer growth.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Seth Wander, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2022-12-25
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959891 on ClinicalTrials.gov