Clinical Trials /

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

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 16298
  • SECONDARY ID: 2014-002113-39
  • NCT ID: NCT02258464

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
Radium-223 dichloride (Xofigo, BAY88-8223)Radium-223 dichloride + hormonal therapy
Placebo (saline)Placebo + hormonal therapy

Purpose

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 Arms

NameTypeDescriptionInterventions
Radium-223 dichloride + hormonal therapyExperimentalUp 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
  • Radium-223 dichloride (Xofigo, BAY88-8223)
Placebo + hormonal therapyPlacebo ComparatorUp to 6 cycles of saline injection (placebo) (Randomized) + Hormonal therapy background treatment to be prescribed by Principal Investigator
  • Placebo (saline)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Symptomatic skeletal event free survival (SSE-FS).
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Time to opiate use for cancer pain
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Time to pain progression (only in subjects with baseline worst pain score ≤8)
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Time to cytotoxic chemotherapy
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Radiological progression-free survival (rPFS)
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Frequency of abnormalities in laboratory examinations.
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:Pain Improvement Rate
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:
Measure:To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy
Time Frame:From time of randomization up to 25 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bayer

Trial Keywords

  • Breast Cancer

Last Updated

August 23, 2017