Seribantumab + Fulvestrant in Postmenopausal Women with MBC

SHERBOC: A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Systemic Therapy

January 17, 2018

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Morales, Leticia; Pelley, Jennifer

    Trial Phone: 321.841.2285 ; 321.841.6696 ; 321.841.4348

  • IRB No: 17.082.07

    Protocol Abbrev: MM-121-02-02-10

    Principal Investigator: Regan Derek Rostorfer, MD

    Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Moroose, Rebecca MD; Shah, Nikita MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: Merrimack

    Treatment: Medication

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Seribantumab

    ClinicalTrials.gov ID: NCT03241810

  • Objective

    The primary objective of this study is to determine whether the combination of seribantumab plus fulvestrant is more effective than placebo plus fulvestrant, based on investigator assessed Progression Free Survival (PFS) in HRG positive patients.

  • Key Eligibility

    Histologically or cytologically confirmed ER+ and/or PR+ (with staining of > 1% cells) breast cancer
    Confirmed postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
    HER2 negative per ASCO/CAP guidelines
    A positive in-situ hybridization (ISH) test for heregulin with a score of ≥1+, as determined by centralized testing of unstained tumor tissue
    Must have at least one lesion amenable to either core needle biopsy or fine needle aspiration
    Progressed following at least one but no more than two prior systemic therapies in the locally advanced or metastatic disease setting
    Received prior CDK inhibitor based therapy for locally advanced or metastatic disease Documented progression of locally advanced or metastatic disease as defined by RECIST v1.1. Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lytic lesions visible on a CT or MRI and have documented disease progression on prior therapy based on the appearance of new lesions.
    Patients with bone-only lesions who have received radiation to those lesions must have documented progression following radiation therapy.
    ECOG Performance Score (PS) of 0 or 1
    Adequate bone marrow reserves as evidenced by:
    •   ANC > 1500/μl
    •   Platelet count > 100,000/μl; and
    •   Hemoglobin > 9 g/dL
    Adequate hepatic function as evidenced by:
    Serum total bilirubin ≤ 1.5 x ULN except for patients with Morbus Gilbert
    Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present, and ≤ 5 x ULN of Alkaline Phosphatase is acceptable if bone metastases are present)
    Adequate renal function as evidenced by a serum creatinine ≤ 1.5 x ULN
    Recovered from clinically significant effects of any prior surgery, radiotherapy, or other antineoplastic therapy.
    Patients may be treated with bone modifying agents such as bisphosphonates or receptor activator of nuclear factor kappa-B (RANK)-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment > 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change