Last updated on September 2014

Study of Radium-223 Dichloride Versus Placebo and Treatment With Exemestane / Everolimus in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Neoplasms
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other:
    Women (≥18 years of age) with metastatic breast cancer not amenable to curative
    treatment by surgery or radiotherapy.
    Documentation of histological or cytological confirmation of estrogen receptor
    positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
    Documentation of menopausal status: postmenopausal subjects or pre-menopausal subjects
    with ovarian radiation or concomitant therapy with a luteinizing hormone-releasing
    hormone (LH-RH) agonist/antagonist are eligible.
    Subjects with bone dominant disease with at least 2 skeletal metastases identified at
    baseline by bone scintigraphy and confirmed by computed tomography (CT)/magnetic
    resonance imaging (MRI).
    Subjects must have received at least one line of hormonal therapy in the metastatic
    etting.
    Subjects who are eligible as per the Investigator's assessment and according to the
    local label for treatment with exemestane and everolimus as a second line or greater
    of hormone therapy in a metastatic setting.
    Subjects must have experienced recurrent/progressive disease following treatment with
    a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or
    metastatic setting
    Subjects must have experienced no more than two skeletal-related events (SREs) prior
    to study entry defined as: need for external beam radiotherapy (EBRT) to bone pain,
    pathological bone fracture (excluding major trauma), spinal cord compression and/or
    orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
    Subjects must be on therapy with bisphosphonates or denosumab for at least 1 month
    before start of study treatment.
    Adequate hematological, liver and kidney function.

You may not be eligible for this study if the following are true:

  • Subjects with Inflammatory breast cancer.
    Patients with immediately life-threatening visceral disease for whom chemotherapy is
    preferred treatment option.
    Subjects who have either received chemotherapy for metastatic disease or are
    considered by the treating investigator to be appropriate candidates for chemotherapy
    as current treatment for metastatic breast cancer are excluded. Chemotherapy
    administered for adjuvant/neo adjuvant disease is acceptable provided it was
    administered at least 1 year prior to study entry.
    Subjects who received prior treatment or are already receiving everolimus treatment
    prior to study entry are not eligible.
    Subjects with known or history of brain metastases or leptomeningeal disease: subjects
    with neurological symptoms must undergo a contrast CT scan or MRI of the brain within
    28 days prior to randomization to exclude active brain metastasis. Imaging of the
    central nervous system (CNS) is otherwise not required.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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