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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

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Radium-223 dichloride (Xofigo, BAY88-8223) Drug: Placebo (saline) Other: Background hormonal therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2, 2015
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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)

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.

Placebo Comparator: Placebo + hormonal therapy
Up to 6 cycles of saline injection (placebo) (Randomized) + Hormonal therapy background treatment to be prescribed by Principal Investigator
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.




Primary Outcome Measures :
  1. Symptomatic skeletal event free survival (SSE-FS). [ Time Frame: From time of randomization up to 25 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From time of randomization up to 25 months ]
  2. Time to opiate use for cancer pain [ Time Frame: From time of randomization up to 25 months ]
  3. Time to pain progression (only in subjects with baseline worst pain score ≤8) [ Time Frame: From time of randomization up to 25 months ]
  4. Time to cytotoxic chemotherapy [ Time Frame: From time of randomization up to 25 months ]
  5. Radiological progression-free survival (rPFS) [ Time Frame: From time of randomization up to 25 months ]
  6. Frequency of abnormalities in laboratory examinations. [ Time Frame: From time of randomization up to 25 months ]
  7. Pain Improvement Rate [ Time Frame: From time of randomization up to 25 months ]
  8. To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy [ Time Frame: From time of randomization up to 25 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258464


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02258464     History of Changes
Other Study ID Numbers: 16298
2014-002113-39 ( EudraCT Number )
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Radium Ra 223 dichloride
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents