A Study of Alpharadin® in Breast Cancer Patients With Bone Dominant Disease no Longer Considered Suitable for Hormone Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Algeta ASA.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Algeta ASA
ClinicalTrials.gov Identifier:
NCT01070485
First received: February 17, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The purpose of the study is to investigate if multiple (up to four) intravenous injections of 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 Alpharadin will be assessed.


Condition Intervention Phase
Breast Cancer
Bone Metastases
Drug: Radium-223 chloride (Alpharadin)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase IIa, Non-randomised, Study of Alpharadin® in Breast Cancer Patients With Bone Dominant Disease no Longer Considered Suitable for Endocrine Therapy

Resource links provided by NLM:


Further study details as provided by Algeta ASA:

Primary Outcome Measures:
  • Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Biochemical markers (additional bone markers and CA15.3) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
A maximum of 4 intravenous injections of Alpharadin, separated by an interval of 4 weeks. Activity doses of 50 kBq/kg b.w.
Drug: Radium-223 chloride (Alpharadin)
A maximum of 4 intravenous injections of Alpharadin separated by an interval of 4 weeks. Fixed activity doses of 50 kBq/kg b.w.
Other Name: Alpharadin

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Histological or cytological evidence of primary breast cancer.
  3. 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.
  4. 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).
  5. 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.
  6. Latest endocrine therapy stopped at least 2 weeks prior to treatment start.
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 - 2.
  8. Life expectancy ≥6 months.
  9. Patient fulfils the following laboratory requirements:

    • White Blood Cell Count (WBC) ≥3,000/mm3
    • Absolute Neutrophil Count (ANC) ≥1,500/mm3
    • Platelet (PLT) count ≥100,000/mm3
    • Haemoglobin (HGB) ≥9 g/dl
    • Bilirubin ≤2.0 mg/dl
    • Aspartate aminotransferase (AST) and Alkaline aminotransferase (ALT) ≤3 times upper institutional limit of the normal range
    • Serum creatinine ≤2.0 mg/dl
  10. Patient must be able and willing to sign an informed consent form indicating that she is aware of the investigational nature of this study in keeping with the policies of the institution, and must have provided written authorisation for use and disclosure of protected health information.
  11. Patient must be willing and able to comply with the protocol and agree to return to the hospital for follow-up visits and examination.

Exclusion Criteria:

  1. Received an investigational drug within 4 weeks prior to the administration of Alpharadin, or is scheduled to receive one during the treatment period.
  2. 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.
  3. Is likely to require chemotherapy or immunotherapy within the 16 weeks treatment period.
  4. Presence of imminent or established spinal cord compression based on clinical findings and/or MRI.
  5. Presence of other currently active (relapse within the last 3 years) malignancy (except non melanoma skin cancer) that are not breast cancer metastases.
  6. 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.
  7. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070485

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
CHU du Sart Tilman
Liège, Belgium, 4000
Norway
Oslo University Hosptial, The Radium Hospital
Oslo, Norway, 0310
United Kingdom
Weston Park Hospital, Cancer Clinical Trials Centre, Academic Unit of Clinical Oncology
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
Algeta ASA
Bayer
Investigators
Principal Investigator: Robert E Coleman, MD Weston Park Hospital, Cancer Research Centre, Academic Unit of Clinical Oncology
  More Information

No publications provided

Responsible Party: Algeta ASA
ClinicalTrials.gov Identifier: NCT01070485     History of Changes
Other Study ID Numbers: BC1-09
Study First Received: February 17, 2010
Last Updated: October 4, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency

Keywords provided by Algeta ASA:
Bone markers
Safety

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014