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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:




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There are 89 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:




How clear is this clinincal trial information?


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