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Androgen Receptor Inhibitor

Taselisib 4 mg for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Vandana Abramson, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 months
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of taselisib when given with enzalutamide for treating patients with androgen receptor positive triple-negative breast cancer.

Eligible Conditions
  • Breast Cancer
  • No change needed.
  • Progesterone Receptor Positive

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Benefit Rate (CBR) - Phase II
Maximum Tolerated Dose (MTD) of Taselisib Combined With 160mg Enzalutamide - Phase I
Secondary outcome measures
Overall Progression-Free Survival (PFS) of Patients Treated With Enzalutamide and Taselisib
Pharmacokinetic Profile

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Taselisib 8 mgExperimental Treatment4 Interventions
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
Group II: Taselisib 6 mgExperimental Treatment4 Interventions
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
Group III: Taselisib 4 mgExperimental Treatment4 Interventions
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
Group IV: Taselisib 2 mgExperimental Treatment4 Interventions
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
Group V: Enzalutamide + TaselisibExperimental Treatment4 Interventions
Patients receive enzalutamide PO QD starting on day 1 of cycle 1, and will receive Taselisib PO QD starting on day 1 of cycle 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group VI: Cross-OverExperimental Treatment4 Interventions
Upon progression of disease, patients on the enzalutamide only arm will be allowed to crossover to enzalutamide + taselisib (must begin no later than 21 days after the clinic visit at which disease progression is determined) Enzalutamide and Taselisib will be taken PO QD
Group VII: EnzalutamideActive Control3 Interventions
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to receive Enzalutamide + Taselisib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taselisib
2014
Completed Phase 2
~2230
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,327 Total Patients Enrolled
13 Trials studying Breast Cancer
1,575 Patients Enrolled for Breast Cancer
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,903 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,945 Total Patients Enrolled
1 Trials studying Breast Cancer
214 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Vandana Abramson 2015. "Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02457910.
~3 spots leftby Apr 2025
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