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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070485
• Other study ID #: 15468
• Secondary ID: 2009-012189-30BC
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2010
• Last updated: June 24, 2014
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Metastases
• Breast Cancer
• Breast Neoplasms

Intervention

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.).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP)		16 weeks	No
Secondary	All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity		1 year	Yes
Secondary	Biochemical markers (additional bone markers and CA15.3)		16 weeks	No
Secondary	Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)		1 year	No
Secondary	Pain		1 year	No

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