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

Official Title

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

Summary:

The objective of this study is 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.

Trial Description

Primary Outcome:

  • Symptomatic skeletal event free survival (SSE-FS).
Secondary Outcome:
  • Overall survival
  • Time to opiate use for cancer pain
  • Time to pain progression (only in subjects with baseline worst pain score ≤8)
  • Time to cytotoxic chemotherapy
  • Radiological progression-free survival (rPFS)
  • Frequency of abnormalities in laboratory examinations.
  • Pain Improvement Rate
  • To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society