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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dosing till end of study, up to 72.6 months
Awards & highlights
Study Summary
This trial will focus on safety and efficacy of radium 223 in subjects with HER2 negative hormone receptor positive breast cancer. Data collection will be reduced to focus on acute safety, SSE, and OS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dosing till end of study, up to 72.6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dosing till end of study, up to 72.6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptomatic Skeletal Event-free Survival (SSE-FS)
Secondary outcome measures
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Number of Participants With New Primary Malignancies
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
+7 moreOther outcome measures
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Number of Participants With New Primary Malignancies During Study Treatment Till Primary Analysis
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Radium-223 dichloride + exemestane/everolimusExperimental Treatment3 Interventions
Up to 6 cycles of radium-223 dichloride 50kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) (randomized). Participants will also receive exemestane, 25-mg tablet once daily (after a meal), and everolimus, 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice.
Group II: Placebo + exemestane/everolimusPlacebo Group3 Interventions
Up to 6 cycles of saline injection (placebo) (randomized). Participants will also receive exemestane, 25-mg tablet once daily (after a meal), and everolimus, 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
2003
Completed Phase 4
~7880
Radium-223 dichloride (Xofigo, BAY88-8223)
2014
Completed Phase 3
~11100
Everolimus
2010
Completed Phase 4
~1510
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,154 Total Patients Enrolled
20 Trials studying Breast Cancer
128,370 Patients Enrolled for Breast Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,656 Total Patients Enrolled
5 Trials studying Breast Cancer
1,520 Patients Enrolled for Breast Cancer
Frequently Asked Questions
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