BC1-09 Breast - for healthcare professionals.

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 (trial BC1-09)

Patient enquiries:

Below are details of the phase IIa clinical study with Alpharadin^®, including main inclusion and exclusion criteria, with a list of clinical centers recruiting patients or soon to be recruiting patients. Additional information may be found at www.clinicaltrial.gov.

Patients interested in participating in this trial are advised to discuss this information with their medical doctor.

For further information from Algeta:
E-mail to alpharadin@algeta.com

Phone: +47 23 00 79 90

This is an exploratory, open-labelled, non-randomised phase IIa study to investigate the safety and efficacy of Alpharadin^® (radium-223 chloride) in breast cancer patients with bone-dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. Approximately 20 patients are planned to be included.

The treatment consists of a maximum of 4 intravenous injections of Alpharadin^® (50 kBq/kg b.w.). Each study drug administration will be separated by an interval of 4 weeks. Patients will be monitored for 1 year from first administration of study drug.

Primary Objective:

To investigate if multiple 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.

Secondary Objectives:

To evaluate the safety of multiple intravenous injections of Alpharadin^®
To evaluate potential benefit, palliative and/or anti-tumor effect of Alpharadin^®
To evaluate long-term radiation toxicity

Exploratory Objective:

To determine the metabolic effects on bone metastases as a result of Alpharadin^® treatment
To determine the change in number of circulating tumor cells (CTC) as a result of Alpharadin^® treatment

Main Inclusion Criteria:

Patient is female, and either post-menopausal or surgically sterile or in therapy-induced premature menopause.
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.
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.
Latest endocrine therapy stopped at least 2 weeks prior to treatment start.

Main 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 adverse reactions 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 Magnetic Resonance Imaging (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.
Patients with any other serious illness or medical condition.

Co-ordinating investigator for the study:
Prof. Robert Coleman
Cancer Research Centre
Academic Unit of Clinical Oncology
Weston Park Hospital
Sheffield, S10 2SJ,
United Kingdom

Participating Countries:

United Kingdom:
Weston Park Hospital, Sheffield                                                                                             Open for recruitment

Belgium:
Department of Nuclear Medicine, Jules Bordet Institute, Brussels                                 Open for recruitment

Norway:
The Norwegian Radium Hospital, Oslo                                                                                Open for recruitment