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



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 4, 2015
End Date:August 30, 2019

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A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases

The objective of this study is to assess efficacy and safety of radium 223 dichloride in
subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor
positive breast cancer with bone metastases treated with exemestane and everolimus.


Inclusion Criteria:

- 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
setting.

- 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.

Exclusion Criteria:

- 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.
We found this trial at
20
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