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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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-08-10

Study results available
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Summary

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

Conditions

  • Breast Neoplasms

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

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)

DRUG

Placebo (saline)

Up to 6 cycles of saline injection

OTHER

Background hormonal therapy

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-02
Primary Completion
2019-08-13
Completion
2019-08-13

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Ireland
  • Israel
  • Netherlands
  • Norway
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258464 on ClinicalTrials.gov