Trial Condition(s):
Study of radium-223 dichloride versus placebo and hormonal treatment as background therapy in subjects with bone predominant HER2 (Human epidermal growth factor receptor 2) negative hormone receptor positive metastatic breast cancer
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy
- Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available. - Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy. - Documentation of menopausal status: post menopausal or premenopausal subjects are eligible. - Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases is allowed. - Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. - Subjects must have received at least one line of hormonal therapy in the metastatic setting - Subjects who are eligible for further standard of care endocrine treatment. - Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo). - Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, 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 bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment. - Adequate hematological, liver and kidney function.
- Subjects with Inflammatory breast cancer. - 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. - 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. - Known presence of osteonecrosis of jaw. - Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option. - Lymphangitic carcinomatosis. - Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.
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Locations Investigative Site Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Zerifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Jerusalem, Israel, 9103102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Sheffield, United Kingdom, S10 2SJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Ann Arbor, United States, 48109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Madrid, Spain, 28033 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Sevilla, Spain, 41071 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Cork, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Gdynia, Poland, 81-519 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Bialystok, Poland, 15-027 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Helsinki, Finland, 00290 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Tampere, Finland, FIN-33520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Essen, Germany, 45147 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Madrid, Spain, 28041 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Zaragoza, Spain, 50009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Cedar Rapids, United States, 52403 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Pittsburgh, United States, 15213-3180 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Pontiac, United States, 48341 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Annapolis, United States, 21401 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site New Haven, United States, 06520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site La Jolla, United States, 92093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Hong kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site København, Denmark, 2100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Herlev, Denmark, 2730 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Seoul, South Korea, 03722 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Busan, South Korea, 49241 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Incheon, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site A Coruña, Spain, 15009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site London, Canada, N6A 4L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Winnipeg, Canada, R3E 0V9 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Oslo, Norway, 0424 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site NIEUWEGEIN, Netherlands, 3435 CM | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site SAINT CLOUD, France, 92210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Taunton, United Kingdom, TA1 5DA | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Houston, United States, 77230 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Singapore, Singapore, 119074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Cottingham, United Kingdom, HU16 5JQ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Aarau, Switzerland, 5001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Dublin, Ireland, 7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Newmarket, Canada, L3Y 2P9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Ostrava, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site PLYMOUTH, United Kingdom, PL6 8DH | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Bakersfield, United States, 93309 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site Daegu, South Korea, 42601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Investigative Site ANGERS CEDEX, France, 49055 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2