Last updated on September 2014

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy 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:
    Documentation of histological or cytological confirmation of estrogen receptor
    positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
    Women (≥18 years of age) with metastatic breast cancer not amenable to curative
    treatment by surgery or radiotherapy.
    Documentation of menopausal status: post menopausal or premenopausal subjects are
    Subjects with bone dominant disease with at least 2 skeletal metastases identified at
    baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI).
    Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph
    nodes)and/or visceral metastases is allowed.
    Measurable or non-measurable disease (but radiologically evaluable) according to
    Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
    Subjects must have received at least one line of hormonal therapy in the metastatic
    Subjects who are eligible for further standard of care endocrine treatment.
    Subjects enrolled in the current study must start treatment with the single hormone
    agent either within 15 days prior to randomization or after randomization (before or
    imultaneously to the first injection of Ra-223/placebo).
    Subjects must have experienced no more than two skeletal-related events (SREs) prior
    to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone,
    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 bisphosphonate and denosumab. and are required to
    have been on such therapy 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.
    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.
    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.
    Known presence of osteonecrosis of jaw.
    Patients with immediately life-threatening visceral disease, for whom chemotherapy is
    the preferred treatment option.
    Lymphangitic carcinomatosis.
    Patients with ascites requiring paracentesis within 2 weeks prior to study entry
    (signature of informed consent) and during the screening period.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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