Clinical Trials /

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer

NCT02750358

Description:

This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Feasibility Study of Adjuvant <span class="go-doc-concept go-doc-intervention">Enzalutamide</span> for the Treatment of Early Stage <span class="go-doc-concept go-doc-biomarker">AR</span> (+) <span class="go-doc-concept go-doc-keyword">Triple Negative</span> Breast Cancer

Title

  • Brief Title: Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer
  • Official Title: Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR(+) Triple Negative Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02750358

    ORG ID: 15-307

    Trial Conditions

    Breast Cancer

    Early Stage

    Triple Negative Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Enzalutamide Enzalutamide

    Trial Purpose

    This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an
    androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+)
    triple negative breast cancer (TNBC).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Enzalutamide Experimental 160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window). Enzalutamide

    Eligibility Criteria

    The study population for Step 1 must meet the following eligibility criteria:

    Inclusion Criteria:

    - Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative
    breast cancer is defined as ER 0%, PR 0% and HER2 0 or 1+ or FISH not amplified if
    IHC 2+.

    - AR testing may be performed while patient is undergoing other adjuvant therapy (i.e.,
    surgery, chemotherapy, radiation).

    - Willing and able to provide informed consent. Woman at least 18 years of age.

    - Patient is a candidate for treatment of their early stage breast cancer.

    The study population for Step 2 will meet the eligibility criteria:

    Inclusion Criteria:

    - Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative
    breast cancer is defined as ER 0%, PR 0% and HER2 0 or 1+ or FISH not amplified if
    IHC 2+.

    - AR(+), defined as 1% nuclear staining by IHC testing. The assessment of AR
    expression may have been performed any time in the past and is not limited to
    participation in Step 1.

    - Any neoadjuvant or adjuvant chemotherapy regimen is permitted. Prior chemotherapy for
    the treatment of this breast cancer is not required.

    - At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution
    of any toxicity to Grade 1 or less, excluding alopecia.

    - Patients are eligible to participate within 6 months of completion of therapy for
    their breast cancer. This includes prior radiation therapy if needed.

    - ECOG performance status of 0 or 1.

    - Willing and able to provide informed consent.

    - Woman at least 18 years of age.

    - Able to swallow study drug and comply with study requirements.

    - Women of childbearing potential must have a negative pregnancy test and must agree to
    use 2 acceptable methods of birth control (one of which must include a condom as a
    barrier method of contraception) starting at screening and continuing throughout the
    study period and for 3 months after final study drug administration.

    - Is not breastfeeding at screening and will not breastfeed throughout the study period
    and for at least 3 months after final drug administration.

    Exclusion Criteria:

    Each patient eligible to participate in this study must NOT meet any of the following
    exclusion criteria.

    - Any severe concurrent disease, infection or comorbid condition that renders the
    patient inappropriate for enrollment in the opinion of the investigator or interferes
    with the patient's ability to participate in the study requirements.

    - Evidence of metastatic/Stage 4 breast cancer

    - History of another invasive cancer within 5 years with the exceptions of nonmelanoma
    skin cancers and AJCC Stage 0 or 1 cancers that have a remote probability of
    recurrence in the opinion of the investigator

    - Absolute neutrophil count < 1500/L, platelet count < 75,000/L, or hemoglobin < 9
    g/dL (5.6 mmol/L).

    - Total bilirubin > 1.5 times upper limit of normal (ULN) unless an alternate
    nonmalignant etiology exists (eg, Gilbert's disease). Aspartate aminotransferase
    (AST) or alanine aminotransferase (ALT) > 3 times ULN.

    - Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute
    calculated using the Cockcroft-Gault equation.

    - History of seizure or any condition that may predispose to seizure (e.g., prior
    cortical stroke, significant brain trauma) at any time in the past. Also, history of
    loss of consciousness or transient ischemic attack within 12 months before day 1

    - An active gastrointestinal disorder affecting absorption (eg, gastrectomy, active
    peptic ulcer disease, uncontrolled celiac)

    - Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
    capsule components, including Labrasol, butylated hydroxyanisole and butylated
    hydroxytoluene.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    The treatment discontinuation rate of enzalutamide in the adherent population

    Secondary Outcome Measures

    Trial Keywords

    Enzalutamide

    15-307