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    Association details:
    Biomarker:AR positive
    Cancer:Triple Negative Breast Cancer
    Drug:Xtandi (enzalutamide capsule) (Androgen receptor inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

    Excerpt:
    ...Progression-free survival using Kaplan-Meier curves`Clinical benefit rate will be measured at designated timepoints as listed per protocol`Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer...
    Trial ID:
    NCT02130700
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer

    Excerpt:
    ...AR-positivity is defined as > 10% of nuclear staining....
    Trial ID:
    NCT02689427
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

    Excerpt:
    ...AR positive tumours defined as any nuclear AR staining by IHC (enrolment may be based on local pathology findings; subsequent review of AR expression by central pathology laboratory will be carried out) 2....
    Trial ID:
    NCT02676986
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Breast Cancer Res Treat
    Title:

    Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: a feasibility study

    Published date:
    08/20/2022
    Excerpt:
    This study assessed the feasibility of adjuvant enzalutamide, an AR antagonist, in early-stage, AR-positive (AR +) TNBC....The 1-year, 2-year, and 3-year DFS were 94%, 92% , and 80%, respectively….This clinical trial demonstrates that adjuvant enzalutamide is a feasible and well-tolerated regimen in patients with an early-stage AR + TNBC.
    DOI:
    10.1007/s10549-022-06669-2
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    JCO Precis Oncol
    Title:

    Androgen Receptor Immunohistochemistry as a Companion Diagnostic Approach to Predict Clinical Response to Enzalutamide in Triple-Negative Breast Cancer

    Excerpt:
    At a threshold of 10%, 74.6% of patients were AR positive, leading to 30% PPV, 90% sensitivity, and 30% specificity. These patients showed a significantly higher median progression-free survival (hazard ratio, 0.56; 95% CI, 0.36 to 0.88; P = .011) and overall survival (hazard ratio, 0.54; 95% CI, 0.32 to 0.91; P = .019)...At a threshold of ≥ 10% nuclear expression, the AR was associated with TNBC response to enzalutamide.
    DOI:
    10.1200/PO.17.00075
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    AACR-II 2020
    Title:

    Abstract 6271: Hormone receptor inhibition as a strategy for radiosensitization of breast cancer

    Published date:
    05/15/2020
    Excerpt:
    AR inhibition with enzalutamide, apalutamide, and darolutamide showed limited single agent growth inhibition efficacy in AR+ TNBC and AR+, ER+ breast cancer cell lines (IC50 > 10 μM).
    DOI:
    10.1158/1538-7445.AM2020-6271