Trial Condition(s):
Breast Neoplasms
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
Bayer Identifier:
16298
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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 Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Zerifin, Israel, 7030000 | 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 |
Locations Investigative Site Jerusalem, Israel, 9112001 | 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 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 Linz, Austria, 4020 | 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 Sheffield, United Kingdom, S10 2SJ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cork, Ireland | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Gdynia, Poland, 81-519 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bialystok, Poland, 15-027 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Helsinki, Finland, 00290 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tampere, Finland, FIN-33520 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Málaga, Spain, 29010 | 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, 28040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Zaragoza, Spain, 50009 | 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 Cedar Rapids, United States, 52403 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pittsburgh, United States, 15213-3180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pontiac, United States, 48341 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Annapolis, United States, 21401 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site New Haven, United States, 06520 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hong kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site København, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Herlev, Denmark, 2730 | 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 Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 03722 | 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 Incheon, South Korea | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site A Coruña, Spain, 15009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site London, Canada, N6A 4L6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Winnipeg, Canada, R3E 0V9 | 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 NIEUWEGEIN, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site SAINT CLOUD, France, 92210 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Taunton, United Kingdom, TA1 5DA | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Northwood, United Kingdom, HA6 2RN | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Houston, United States, 77230 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cottingham, United Kingdom, HU16 5JQ | 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 Dublin, Ireland, 7 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Newmarket, Canada, L3Y 2P9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Praha 2, Czech Republic, 12808 | 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 |
Locations Investigative Site Bakersfield, United States, 93309 | 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 ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site ANGERS CEDEX, France, 49055 | 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 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
Primary Outcome
- Symptomatic skeletal event free survival (SSE-FS)Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any causeTimeframe: Up to approximately 51 months
Secondary Outcome
- Overall survivalTime from randomization to death from any causeTimeframe: Up to approximately 51 months
- Time to opiate use for cancer painInterval from the date of randomization to the date of opiate useTimeframe: Up to approximately 51 months
- Time to pain progressionTime from randomization to the first date a participants (only in participants with baseline WPS ≤8) experiences pain progression based on worst pain score (WPS) ranging from 0 to 10 and analgesic use. Pain progression is defined as an increase of 2 or more points in the “Worst pain in 24 hours” score from baseline observed at 2 consecutive evaluations ≥4 weeks apart or an increase in pain management (IPM) with respect to baseline, whichever occurs firstTimeframe: Up to approximately 51 months
- Pain Improvement RateThe percentage of participants (baseline WPS>=2) with confirmed pain improvement at any time point. Confirmed pain improvement is defined as a 2 point decrease in worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apartTimeframe: Up to approximately 51 months
- Time to cytotoxic chemotherapyTime from the date of randomization to the date of the first cytotoxic chemotherapyTimeframe: Up to approximately 51 months
- Radiological progression-free survival (rPFS)Time from the date of randomization to the date of first radiological progression or death (if death occurs before progression)Timeframe: Up to approximately 51 months
- Number of participants with treatment-emergent adverse eventsAny event arising or worsening after the start of study drug administration until 30 days after the last study medication intakeTimeframe: Up to approximately 7 months
- Number of participants with post-treatment adverse events including additional malignancies and chemotherapy related adverse eventsAEs related to the study drug, all occurrences of additional malignancies, febrile neutropenia and hemorrhage in subjects receiving chemotherapy, bone fractures and bone associated events (regardless of severity and relationship to study drug), and some symptoms needed for the characterization of an symptomatic skeletal eventTimeframe: From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months
Additional Information
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