check_circleStudy Completed

Breast cancer, Bone Metastases

BAY88-8223, Alpharadin, Breast Cancer pts with bone dominant

Trial purpose

The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.

Key Participants Requirements

Sex

Female

Age

21 - N/A

Trial summary

Enrollment Goal
23
Trial Dates
January 2010 - January 2012
Phase
Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Weston Park Hospital, Cancer Clinical Trials Centre, Academic Unit of Clinical OncologySheffield, United Kingdom
Completed
Institut Jules BordetBrussels, 1000, Belgium
Completed
Oslo University Hosptial, The Radium HospitalOslo, 0310, Norway
Completed
CHU du Sart TilmanLiège, 4000, Belgium

Primary Outcome

  • Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP)
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    Yes
  • Biochemical markers (additional bone markers and CA15.3)
    date_rangeTime Frame:
    16 weeks
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    Safety Issue:
    No
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    No
  • Pain
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    No

Trial design

An open-label Phase IIa, non-randomized study of Alpharadin® in breast cancer patients with bone dominant disease no longer considered suitable for endocrine therapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1