Breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for further endocrine therapy MedDRA version: 9.1 Level: LLT Classification code 10027452 Term: Metastases to bone
Conditions
Interventions
Product Name: Alpharadin
Product Code: Radium-223
Pharmaceutical Form: Solution for injection
INN or Proposed INN: radium-223 chloride
CAS Number: 444811-40-9
Current Sponsor code: Radium-223
Concentr
Sponsors
Algeta ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 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. 6. Latest endocrine therapy stopped at least 2 weeks prior to treatment start. 7. 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 • Urine NTX =20 nmol/mmol creatinine 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 adverse reactions (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 Magnetic Resonance Imaging (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. 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 (New York Heart Association (NYHA) Heart Failure Class III or IV) • Crohn’s disease or ulcerative colitis • Bone marrow myelodysplasia • Unmanageable faecal incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: • To evaluate the safety of multiple intravenous injections of Alpharadin • To evaluate potential benefit, palliative and/or anti-tumour 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 tumour cells (CTC) as a result of Alpharadin treatment.;Primary end point(s): To evaluate the effect of Alpharadin on changes in urine levels of NTX (uNTX) and serum bone specific alkaline phosphatase (bALP) at 16 weeks. | — |
Countries
Belgium, United Kingdom
Outcome results
None listed