Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070485
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.

Condition or disease Intervention/treatment Phase
Breast Cancer Bone Metastases Drug: Radium-223 chloride (BAY88-8223) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase IIa, Non-randomized Study of Alpharadin® in Breast Cancer Patients With Bone Dominant Disease no Longer Considered Suitable for Endocrine Therapy
Study Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Radium-223 dichloride (Xofigo, BAY 88-8223)
Patients were to receive 4 intravenous administrations of Radium-223 at a dose of 50 kBq/kg body weight (b.w) at intervals of 4 weeks. Radium-223 was given as add-on therapy to existing bisphosphonate therapy.
Drug: Radium-223 chloride (BAY88-8223)
The required volume of study drug to be administered to a patient was calculated using the patient's body weight (50 kBq/kg b.w.).

Primary Outcome Measures :
  1. Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity [ Time Frame: 1 year ]
  2. Biochemical markers (additional bone markers and CA15.3) [ Time Frame: 16 weeks ]
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: 1 year ]
  4. Pain [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is female, and either post-menopausal (cessation of menses for more than 1 year) or surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) or in therapy-induced premature menopause with LHRH agonists. If of childbearing potential the result of a urine human chorionic gonadotropin pregnancy test, performed on the same day as and with the result known before study drug administration, must be negative.
  • Histological or cytological evidence of primary breast cancer.
  • Bone dominant disease (with or without metastases in soft tissue, lymph nodes and/or skin) with at least one non-irradiated bone metastasis on planar bone scintigraphy/SPECT ± CT within previous the 12 weeks.
  • Patient has unequivocally progressed on endocrine therapy and further benefit from endocrine therapy is considered unlikely (progression must be documented based on imaging and/or other clinically relevant information).
  • Patient has been on bisphosphonate therapy for at least 3 months prior to treatment start and no change to bisphosphonate therapy is expected during the treatment phase of the study, or patient is not being treated with bisphosphonates, and such treatment is not planned to start during the treatment period.
  • Latest endocrine therapy stopped at least 2 weeks prior to treatment start.
  • ECOG PS 0 - 2.
  • Life expectancy ≥6 months.
  • Patient fulfils the following certain laboratory requirements.

Exclusion Criteria:

  • Received an investigational drug within 4 weeks prior to the administration of Alpharadin, or is scheduled to receive one during the treatment period.
  • Received chemotherapy, immunotherapy, or external beam radiation therapy within the last 4 weeks prior to administration of study drug, or has not recovered from acute ARs as a result of such therapy.
  • Is likely to require chemotherapy or immunotherapy within the 16 weeks treatment period.
  • Presence of imminent or established spinal cord compression based on clinical findings and/or MRI.
  • Presence of other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not breast cancer metastases.
  • Presence of unequivocal visceral metastases requiring chemotherapy treatment in the next 6 months, based on Investigator's judgement. Brain metastases are allowed only if well controlled and if not associated with symptoms. Treatment for brain metastasis should have been completed at least 8 weeks prior to treatment start.
  • Patients with any other serious illness or medical condition, such as:

    • any uncontrolled infection
    • clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or heart failure more severe than this (NYHA Heart Failure Class III or IV)
    • Crohn's disease or ulcerative colitis
    • Bone marrow myelodysplasia
    • Unmanageable faecal incontinence

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 identifier (NCT number): NCT01070485

Layout table for location information
Brussels, Belgium, 1000
Liège, Belgium, 4000
Oslo, Norway, 0310
United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT01070485    
Other Study ID Numbers: 15468
2009-012189-30 ( EudraCT Number )
BC1-09 ( Other Identifier: Algeta ASA )
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Radium Ra 223 dichloride
Antineoplastic Agents