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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update)
Up to 6 cycles of saline injection
Prescribed by PI and was provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.
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 cause
Time frame: Up to approximately 51 months
Overall Survival
Time from randomization to death from any cause
Time frame: Up to approximately 51 months
Time to Opiate Use for Cancer Pain
Interval from the date of randomization to the date of opiate use
Time frame: Up to approximately 51 months
Time to Pain Progression
Time 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 first
Time frame: Up to approximately 51 months
Pain Improvement Rate
The 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 apart
Time frame: Up to approximately 51 months
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Unnamed facility
Bakersfield, California, United States
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La Jolla, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Cedar Rapids, Iowa, United States
Unnamed facility
Annapolis, Maryland, United States
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Ann Arbor, Michigan, United States
Unnamed facility
Pontiac, Michigan, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
...and 61 more locations
Time to Cytotoxic Chemotherapy
Time from the date of randomization to the date of the first cytotoxic chemotherapy
Time frame: 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)
Time frame: Up to approximately 51 months
Number of Participants With Treatment-emergent Adverse Events
Any event arising or worsening after the start of study drug administration until 30 days after the last study medication intake
Time frame: Up to approximately 7 months
Number of Participants With Post-treatment Adverse Events Including Additional Malignancies and Chemotherapy Related Adverse Events
AEs 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 event
Time frame: From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months