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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Zrifin, Israel, 7030000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Holon, Israel, 5822012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Jerusalem, Israel, 9103102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Madrid, Spain, 28033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Bialystok, Poland, 15-027 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 8036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bruxelles, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Spokane, United States, 99208-1129 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Watertown, United States, 57201 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site New Haven, United States, 6510 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Busan, South Korea, 49241 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Daegu, South Korea, 42601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Suwon-si, South Korea, 442-723 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site NANTES, France, 44805 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Herne, Germany, 44625 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Oslo, Norway, 0424 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Newark, United States, 07103 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Roma, Italy, 00149 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Taipei City, Taiwan, China, 114 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kaohsiung City, Taiwan, China, 813414 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Poznan, Poland, 61-485 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site PLYMOUTH, United Kingdom, PL6 8DH | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nagoya, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kita-Adachigun, Japan, 362-0806 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Osaka, Japan, 540-0006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site KORTRIJK, Belgium, 8500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site NIMES Cedex 9, France, 30029 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site TOURS, France, 37044 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Cremona, Italy, 26100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Symptomatic skeletal event free survival (SSE-FS).Timeframe: Up to 55 months
Secondary Outcome
- Overall survivalTimeframe: Up to 55 months
- Time to opiate use for cancer painTimeframe: Up to 55 months
- Time to pain progression (only in subjects with baseline worst pain score (WPS) ≤8)Timeframe: Up to 55 months
- Time to cytotoxic chemotherapyTimeframe: Up to 55 months
- Radiological progression-free survival (rPFS)Timeframe: Up to 55 months
- Percentage of participants with pain improvementTimeframe: Up to 55 months
- Number of participants with TEAEsTEAE: Treatment-emergent adverse eventTimeframe: From first dosing up to 30 days after the last administration of study treatments, up to 93 months
- Number of participants with post-treatment chemotherapy related adverse eventsTimeframe: From post-treatment till end of study, up to 93 months
- Number of participants with hematological oxicities: Worst Grade under TreatmentTimeframe: From first dosing up to 30 days after the last administration of study treatments, up to 93 months
- Number of participants with new primary malignanciesTimeframe: From first dosing till end of study, up to 93 months
Additional Information
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