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Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer

NCT02457910 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-22

Study results available
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Summary

This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with enzalutamide may be a better treatment for patients with breast cancer.

Conditions

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Stage IV Breast Cancer
  • Triple-Negative Breast Carcinoma

Interventions

OTHER

Biomarker Analysis

Correlative studies

DRUG

Enzalutamide

Given PO

OTHER

Pharmacological Study

Correlative studies

DRUG

Taselisib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Conquer Cancer Foundation

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Vandana Abramson, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-12-31
Completion
2022-08-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02457910 on ClinicalTrials.gov