Breast Cancer Clinical Trial
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
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
After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.
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.
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.
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There are 89 Locations for this study
Yuma Arizona, 85364, United States
La Jolla California, 92093, United States
Long Beach California, 90813, United States
Los Angeles California, 90033, United States
New Haven Connecticut, 06510, United States
Hollywood Florida, 33021, United States
Ashland Kentucky, 41101, United States
Rockville Maryland, 20850, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Pontiac Michigan, 48341, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Newark New Jersey, 07103, United States
Jamaica New York, 11432, United States
Watertown South Dakota, 57201, United States
Spokane Washington, 99208, United States
Innsbruck , 6020, Austria
Anderlecht , 1070, Belgium
Edegem , 2650, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Angers Cedex , 49055, France
Nantes , 44805, France
NIMES Cedex 9 , 30029, France
Saint Cloud , 92210, France
Tours , 37044, France
Herne Nordrhein-Westfalen, 44625, Germany
Chai Wan , , Hong Kong
Hong Kong , , Hong Kong
Kowloon , , Hong Kong
Afula , 18341, Israel
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Holon , 58220, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Zrifin , 70300, Israel
Bologna Emilia-Romagna, 40138, Italy
Forlì Cesena Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41124, Italy
Roma Lazio, 00149, Italy
Roma Lazio, 00161, Italy
Genova Liguria, 16128, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20132, Italy
Bari Puglia, 70124, Italy
Pisa Toscana, 56126, Italy
Nagoya Aichi, 464-8, Japan
Sapporo Hokkaido, 060-8, Japan
Osakasayama Osaka, 589-8, Japan
Hidaka Saitama, 350-1, Japan
Kita-Adachigun Saitama, 362-0, Japan
Koto-ku Tokyo, 135-8, Japan
Kagoshima , 892-0, Japan
Osaka , 540-0, Japan
Suwon-si Gyeonggido, 442-7, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 42601, Korea, Republic of
Incheon , , Korea, Republic of
Seoul , 05505, Korea, Republic of
Oslo , 0424, Norway
Bialystok , 15-02, Poland
Gdansk , 80-95, Poland
Gdynia , 81-51, Poland
Poznan , 61-48, Poland
Warszawa , 02-78, Poland
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Singapore , 25849, Singapore
Palma de Mallorca Illes Baleares, 07120, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28033, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
Sevilla , 41071, Spain
Aarau Aargau, 5001, Switzerland
Kaoshiung , 81346, Taiwan
Taichung , 40705, Taiwan
Taipei , , Taiwan
Truro Cornwall, TR1 3, United Kingdom
Plymouth Devon, PL6 8, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
Bristol , BS2 8, United Kingdom
Merseyside , CH63 , United Kingdom
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