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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

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ClinicalTrials.gov Identifier: NCT02258464
Recruitment Status : Active, not recruiting
First Posted : October 7, 2014
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 30, 2014
First Posted Date  ICMJE October 7, 2014
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE March 2, 2015
Estimated Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Symptomatic skeletal event free survival (SSE-FS). [ Time Frame: From time of randomization up to 25 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
Symptomatic skeletal event free survival (SSE-FS) [ Time Frame: From time of randomization up to 25 months ]
Change History Complete list of historical versions of study NCT02258464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • Overall survival [ Time Frame: From time of randomization up to 25 months ]
  • Time to opiate use for cancer pain [ Time Frame: From time of randomization up to 25 months ]
  • Time to pain progression (only in subjects with baseline worst pain score ≤8) [ Time Frame: From time of randomization up to 25 months ]
  • Time to cytotoxic chemotherapy [ Time Frame: From time of randomization up to 25 months ]
  • Radiological progression-free survival (rPFS) [ Time Frame: From time of randomization up to 25 months ]
  • Frequency of abnormalities in laboratory examinations. [ Time Frame: From time of randomization up to 25 months ]
  • Pain Improvement Rate [ Time Frame: From time of randomization up to 25 months ]
  • To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy [ Time Frame: From time of randomization up to 25 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • Overall survival [ Time Frame: From time of randomization up to 25 months ]
  • Time to opiate use for cancer pain [ Time Frame: From time of randomization up to 25 months ]
  • Time to pain progression [ Time Frame: From time of randomization up to 25 months ]
  • Time to cytotoxic chemotherapy [ Time Frame: From time of randomization up to 25 months ]
  • Radiological progression-free survival (rPFS) [ Time Frame: From time of randomization up to 25 months ]
  • Frequency of abnormalities in laboratory examinations [ Time Frame: From time of randomization up to 25 months ]
  • Frequency of abnormalities in Adverse Events [ Time Frame: From time of randomization up to 25 months ]
  • Frequency of abnormalities in new primary malignancies [ Time Frame: From time of randomization up to 25 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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 is provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.
Study Arms
  • Experimental: Radium-223 dichloride + hormonal therapy
    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) + Hormonal therapy background treatment to be prescribed by Principal Investigator
    Interventions:
    • Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
    • Other: Background hormonal therapy
  • Placebo Comparator: Placebo + hormonal therapy
    Up to 6 cycles of saline injection (placebo) (Randomized) + Hormonal therapy background treatment to be prescribed by Principal Investigator
    Interventions:
    • Drug: Placebo (saline)
    • Other: Background hormonal therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2014)
227
Estimated Study Completion Date March 15, 2019
Estimated Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
  • Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
  • Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases is allowed.
  • Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  • Subjects must have received at least one line of hormonal therapy in the metastatic setting
  • Subjects who are eligible for further standard of care endocrine treatment.
  • Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
  • Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
  • Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.
  • Adequate hematological, liver and kidney function.

Exclusion Criteria:

  • Subjects with Inflammatory breast cancer.
  • Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
  • Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.
  • Known presence of osteonecrosis of jaw.
  • Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option.
  • Lymphangitic carcinomatosis.
  • Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Ireland,   Israel,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries China,   Czech Republic,   Italy,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02258464
Other Study ID Numbers  ICMJE 16298
2014-002113-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP