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Breast CancerPhase 3ENDEARNCT02929576

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 study testing Enzalutamide and Paclitaxel in people with Breast Cancer, run by Pfizer at 6 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Enzalutamide and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
6 sitesUnited States
Study dates
Sep 2016to Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Houston, Texas, 77030

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Tacoma, Washington, 98405

  • Study site

    The Bronx, New York, 10469

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Wenatchee, Washington, 98801

Other trials in United States

About this study

Official title: A Phase 3, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer

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).

Conditions
Breast Cancer
Being tested
Enzalutamide, Placebo, Paclitaxel
Keywords
metastatic, triple negative
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called Xtandi, MDV3100

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

  • PlaceboDrug

  • PaclitaxelDrug

    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.

Study groups in NCT02929576
Study groupRoleWhat they receive
Double-blind enzalutamide with paclitaxelExperimentalNot described
Receives: Drug: Enzalutamide; Drug: Paclitaxel
Double-blind placebo with paclitaxelPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Paclitaxel
Open-label enzalutamide monotherapy followed by paclitaxelExperimentalAt 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.
Receives: Drug: Enzalutamide; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Measured: Anticipated in about 31 months following first patient enrolled

Secondary outcomes (11)

  1. Overall survival

    Measured: 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

    Measured: Anticipated in about 31 months following first patient enrolled

  3. Time to treatment failure

    Measured: 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.

    Measured: Anticipated in about 31 months following first patient enrolled

  5. Duration of response

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: Anticipated in about 31 months following first patient enrolled

  10. Pharmacokinetics of enzalutamide as assessed by trough plasma concentrations

    Measured: Anticipated in about 31 months following first patient enrolled

  11. Pharmacokinetics of the active metabolite N-desmethyl enzalutamide as assessed by trough plasma concentrations

    Measured: Anticipated in about 31 months following first patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionApr 2019 (estimated)

Why it stopped: Further understanding about the role of androgen signaling in TNBC was required

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02929576
Sponsor's protocol ID
MDV3100-20
Other IDs
2016-000796-25, 2016
Acronym
ENDEAR
Status last verified
Oct 2018
First submitted
7 Sep 2016
Last updated
22 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enzalutamide and Paclitaxel in people with Breast Cancer, run by Pfizer at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Anticipated in about 31 months following first patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.

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