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Radium Ra 223 dichloride

Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks

Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

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)

Radium-223 dichloride (Xofigo, BAY88-8223)

Placebo (saline)

Prescribed by PI and was provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.

Background hormonal therapy

Bayer Study Director

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 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

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

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 from randomization to death from any cause

Interval from the date of randomization to the date of opiate use

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

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 from the date of randomization to the date of the first cytotoxic chemotherapy

Time from the date of randomization to the date of first radiological progression or death (if death occurs before progression)

Any event arising or worsening after the start of study drug administration until 30 days after the last study medication intake

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

Bayer

Adverse events (AEs) included 1) any event arising or worsening after the start of study drug administration until 30 days after the last study medication intake 2) AEs related to study treatment reported beyond 30 days after study medication, all occurrences of additional malignancies, febrile neutropenia and hemorrhage in subjects receiving chemotherapy, bone fractures and bone associated events and and some symptoms needed for the characterization of an symptomatic skeletal event

Radium 223 Dichloride

Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Intend-to-treat (ITT) analysis set: all randomized participants

Due to the premature enrollment discontinuation, reduced sample size, and potentially curtailed active follow up, the planned number of SSE FS events was not achieved, limiting the assessment of the primary efficacy endpoint.

Therapeutic Area Head

The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group

Intent to treat analysis set: all randomized participants

Symptomatic Skeletal Event Free Survival (SSE-FS)

Overall Survival

Safety analysis set: all randomized participants who received at least one study drug administration (radium 223 dichloride or placebo)

Time to Opiate Use for Cancer Pain

Time to Pain Progression

Participants in safety analysis set taken into account for this endpoint analysis

Pain Improvement Rate

Time to Cytotoxic Chemotherapy

Radiological Progression-free Survival (rPFS)

Any TEAE

Radium 223/Placebo related TEAEs

Safety analysis set: all randomized subjects who received at least one dose of study medication (radium 223 dichloride or placebo)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT02258464	Breast Neoplasm...	Radium-223 dich... Placebo (saline... Background horm...	18 Years -	Bayer
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	NCT02258464	Breast Neoplasm...	Radium-223 dich... Placebo (saline... Background horm...	18 Years -	Bayer

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