Trial Condition(s):

Breast Neoplasms

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

Bayer Identifier:

17096

ClinicalTrials.gov Identifier:

NCT02258451

EudraCT Number:

2014-002114-23

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
283
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Zrifin, Israel, 7030000

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

Afula, Israel, 1834111

Status
Completed
 
Locations

Investigative Site

Holon, Israel, 5822012

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9103102

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28033

Status
Completed
 
Locations

Investigative Site

Palma de Mallorca, Spain, 07120

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41071

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28046

Status
Completed
 
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Investigative Site

Pamplona, Spain, 31008

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08041

Status
Completed
 
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Investigative Site

Bari, Italy, 70124

Status
Completed
 
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Investigative Site

Modena, Italy, 41124

Status
Completed
 
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Investigative Site

Genova, Italy, 16128

Status
Completed
 
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Investigative Site

Detroit, United States, 48202

Status
Completed
 
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Investigative Site

Forlì Cesena, Italy, 47014

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Investigative Site

Gdynia, Poland, 81-519

Status
Completed
 
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Investigative Site

Bialystok, Poland, 15-027

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28041

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28050

Status
Completed
 
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Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Investigative Site

Anderlecht, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
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Investigative Site

Spokane, United States, 99208-1129

Status
Completed
 
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Investigative Site

Watertown, United States, 57201

Status
Completed
 
Locations

Investigative Site

Long Beach, United States, 90813

Status
Completed
 
Locations

Investigative Site

Pontiac, United States, 48341

Status
Completed
 
Locations

Investigative Site

New Haven, United States, 06510

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92093

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63110

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Busan, South Korea, 49241

Status
Completed
 
Locations

Investigative Site

Daegu, South Korea, 42601

Status
Completed
 
Locations

Investigative Site

Suwon-si, South Korea, 442-723

Status
Completed
 
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Investigative Site

Incheon, South Korea

Status
Completed
 
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Investigative Site

Kowloon, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

NANTES, France, 44805

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00161

Status
Completed
 
Locations

Investigative Site

Herne, Germany, 44625

Status
Completed
 
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Investigative Site

Oslo, Norway, 0424

Status
Completed
 
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Investigative Site

Newark, United States, 07103

Status
Completed
 
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Investigative Site

Yuma, United States, 85364

Status
Completed
 
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Investigative Site

Pisa, Italy, 56126

Status
Completed
 
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Investigative Site

Roma, Italy, 00149

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
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Investigative Site

SAINT CLOUD, France, 92210

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Completed
 
Locations

Investigative Site

Chai Wan, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Truro, United Kingdom, TR1 3LJ

Status
Completed
 
Locations

Investigative Site

Taunton, United Kingdom, TA1 5DA

Status
Completed
 
Locations

Investigative Site

Bristol, United Kingdom, BS2 8ED

Status
Completed
 
Locations

Investigative Site

Merseyside, United Kingdom, CH63 4JY

Status
Not yet recruiting
 
Locations

Investigative Site

Singapore, Singapore, 119074

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 258499

Status
Completed
 
Locations

Investigative Site

Jamaica, United States, 11432

Status
Completed
 
Locations

Investigative Site

Hollywood, United States, 33021

Status
Completed
 
Locations

Investigative Site

Rockville, United States, 20850

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90033

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Kaoshiung, Taiwan, China, 81346

Status
Completed
 
Locations

Investigative Site

Taichung, Taiwan, China, 40705

Status
Terminated
 
Locations

Investigative Site

Aarau, Switzerland, 5001

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 61-485

Status
Completed
 
Locations

Investigative Site

PLYMOUTH, United Kingdom, PL6 8DH

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 464-8681

Status
Completed
 
Locations

Investigative Site

Hidaka, Japan, 350-1298

Status
Completed
 
Locations

Investigative Site

Kita-Adachigun, Japan, 362-0806

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 540-0006

Status
Completed
 
Locations

Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Investigative Site

KORTRIJK, Belgium, 8500

Status
Completed
 
Locations

Investigative Site

NIMES Cedex 9, France, 30029

Status
Completed
 
Locations

Investigative Site

TOURS, France, 37044

Status
Completed
 
Locations

Investigative Site

Kagoshima, Japan, 892-0833

Status
Completed
 
Locations

Investigative Site

Cremona, Italy, 26100

Status
Completed
 
Locations

Investigative Site

Ashland, United States, 41101

Status
Completed
 
Locations

Investigative Site

ANGERS CEDEX, France, 49055

Status
Completed
 
Locations

Investigative Site

Nottingham, United Kingdom, NG5 1PB

Status
Completed
 

Trial Design