The purpose of this study is to evaluate and compare the clinical benefit and safety of treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic, diagnostic-positive, triple-negative breast cancer (TNBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enzalutamide will be administered as four 40-mg capsules once daily (160 mg/day).
Paclitaxel (90 mg/m2) will be administered by constant-rate intravenous infusion of ≤ 1 hour once weekly for 16 weeks. Dose reductions or alterations to the schedule are allowed to maintain patient safety.
Unnamed facility
Topeka, Kansas, United States
Unnamed facility
Metairie, Louisiana, United States
Unnamed facility
The Bronx, New York, United States
Unnamed facility
Houston, Texas, United States
Progression Free Survival (PFS)
Time frame: Anticipated in about 31 months following first patient enrolled
Overall survival
Time frame: Anticipated in about 40 months following first patient enrolled
PFS assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame: Anticipated in about 31 months following first patient enrolled
Time to treatment failure
Time frame: Anticipated in about 31 months following first patient enrolled
Best overall response
Best overall response is defined as the best tumor response (complete response \[CR\], partial response \[PR\], stable disease, progressive disease, not evaluable) based on investigator assessment per RECIST 1.1 over all tumor assessments performed any time on study. Best objective response rate is defined as the proportion of patients with a best overall response of CR or PR for all patients based on investigator assessment per RECIST 1.1. The 2-sided 95% Confidence Interval (CI) will be reported for each treatment group using the Clopper-Pearson method.
Time frame: Anticipated in about 31 months following first patient enrolled
Duration of response
Time frame: Anticipated in about 31 months following first patient enrolled
Time to second disease progression in patients randomly assigned to enzalutamide monotherapy who subsequently receive paclitaxel
Time frame: Anticipated in about 31 months following first patient enrolled
Clinical benefit rate at 24 weeks (CBR24): From the start of treatment D1 assessed every 8 weeks +/- 1 week while on study treatment
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Unnamed facility
Tacoma, Washington, United States
Unnamed facility
Wenatchee, Washington, United States
CBR (complete, partial response, or stable disease lasting 24 weeks or longer) assessed per RECIST 1.1
Time frame: 24 weeks
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
Time frame: Anticipated in about 31 months following first patient enrolled
Time to functional status deterioration using the Functional Assessment of Cancer Therapy-Breast (FACT-B) trial outcome index (physical, functional, breast) (TOI-PFB)
Time frame: Anticipated in about 31 months following first patient enrolled
Pharmacokinetics of enzalutamide as assessed by trough plasma concentrations
Time frame: Anticipated in about 31 months following first patient enrolled
Pharmacokinetics of the active metabolite N-desmethyl enzalutamide as assessed by trough plasma concentrations
Time frame: Anticipated in about 31 months following first patient enrolled