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WithdrawnNCT02929576ENDEARUpdated Oct 22, 2018

Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer

A Phase 3 interventional study of Enzalutamide and Placebo in Breast Cancer, sponsored by Pfizer. Withdrawn at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Further understanding about the role of androgen signaling in TNBC was required
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Breast Cancer

Keywords

  • metastatic
  • triple negative
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult women and men at least 18 years of age and willing and able to provide informed consent.
  • Has advanced TNBC:
  • TNBC is defined as staining by immunohistochemistry (IHC) \< 1% or Allred score \< 2 for estrogen receptor (ER) and progesterone receptor (PgR), and 0 or 1+ by IHC for human epidermal growth factor receptor 2 (HER2) or negative for gene amplification (average HER2 copy number \< 4 signals/cell; HER2:CEP17 ratio \< 2.0).
  • Advanced disease is defined as locally advanced or metastatic disease not amenable to curative intent surgery or radiotherapy.
  • Has diagnostic-positive status as determined by a central diagnostic testing laboratory.
  • Received 0 or 1 prior line of systemic therapy in the advanced disease setting.
  • Patients who received 1 prior line of therapy for locally advanced or metastatic TNBC must have objective disease progression as assessed by the investigator.
  • Has measurable and/or disease that is not measurable but is evaluable using RECIST 1.1 (eg, bone metastases, pathologic lymph nodes, or skin lesions).
  • Patients with nonmeasurable and nonevaluable TNBC (eg, malignant effusions or bone marrow as the only manifestations of disease) are not eligible for enrollment.
  • Patients with metastatic disease limited to the bone must have disease adequately visualized by computed tomography (CT) with bone windows, magnetic resonance imaging (MRI), or x-ray.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and a life expectancy of at least 3 months from randomization.

Exclusion criteria

Exclusion Criteria:

  • Received a taxane regimen ≥ 28 days in duration in the advanced disease setting.
  • Prior taxane therapy for neoadjuvant and/or adjuvant disease is permitted.
  • A single dose of a taxane given as part of an every-3-weeks regimen is permitted.
  • Two doses of a taxane given as part of a once-weekly regimen is permitted.
  • Had a disease-free interval of ≤ 12 months from the last dose of taxane when used as part of adjuvant therapy for patients who did not receive prior therapy for locally advanced or metastatic breast cancer.
  • Has history of or known central nervous system (CNS) metastasis or active leptomeningeal disease; brain imaging is required for all patients during screening.
  • Received any anticancer agent (commercially available or investigational) within 14 days before randomization.
  • Received treatment with any of the following medications within 14 days before randomization:
  • Estrogens, including hormone replacement therapy
  • Androgens (eg, testosterone, dehydroepiandrosterone)
  • Systemic radionuclides (eg, samarium, strontium)
  • Had major surgery within 4 weeks before randomization.
  • Has a history of another invasive cancer within 3 years before randomization, with the exception of fully treated cancers with a remote probability of recurrence.
  • Has a history of a seizure condition or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma).
  • Has known hypersensitivity to any of the enzalutamide/placebo capsule components.
  • Had a hypersensitivity reaction to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel, unless successfully treated and rechallenged with appropriate premedications.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Double-blind enzalutamide with paclitaxel

    Drug: Enzalutamide · Drug: Paclitaxel

  • Placebo comparator
    Double-blind placebo with paclitaxel

    Drug: Placebo · Drug: Paclitaxel

  • Experimental
    Open-label enzalutamide monotherapy followed by paclitaxel

    At the time of disease progression, enzalutamide treatment will be discontinued and paclitaxel will be administered if considered to be an appropriate treatment by the treating physician until second disease progression.

    Drug: Enzalutamide · Drug: Paclitaxel

Interventions

  • DrugEnzalutamide

    Enzalutamide will be administered as four 40-mg capsules once daily (160 mg/day).

    Also known as: Xtandi, MDV3100

  • DrugPlacebo
  • DrugPaclitaxel

    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.

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Anticipated in about 31 months following first patient enrolled

Secondary outcomes

  1. Overall survival

    Time frame: Anticipated in about 40 months following first patient enrolled

  2. 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

  3. Time to treatment failure

    Time frame: Anticipated in about 31 months following first patient enrolled

  4. 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

  5. Duration of response

    Time frame: Anticipated in about 31 months following first patient enrolled

  6. 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

  7. Clinical benefit rate at 24 weeks (CBR24): From the start of treatment D1 assessed every 8 weeks +/- 1 week while on study treatment

    CBR (complete, partial response, or stable disease lasting 24 weeks or longer) assessed per RECIST 1.1

    Time frame: 24 weeks

  8. 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

  9. 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

  10. Pharmacokinetics of enzalutamide as assessed by trough plasma concentrations

    Time frame: Anticipated in about 31 months following first patient enrolled

  11. 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

07

Study locations

6 sites
  • Topeka, Kansas 66606, United States
  • Metairie, Louisiana 70006, United States
  • Bronx, New York 10469, United States
  • Houston, Texas 77030, United States
  • Tacoma, Washington 98405, United States
  • Wenatchee, Washington 98801, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02929576
Lead sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation, Inc.
Responsible party
Sponsor
First posted
Oct 11, 2016
Start date
Sep 2016
Primary completion
Apr 2019 (estimated)
Last update
Oct 22, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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