None listed
Conditions
Brief summary
The purpose of this study is to assess any benefits of adding a drug called ‘zoledronic acid’ (also known as ZometaTM) to the standard treatments for breast cancer. Zoledronic acid is one of a class of drugs that are known as bisphosphonates. In Australia, bisphosphonates are already approved to treat a number of medical conditions including osteoporosis (thinning of the bones), and in cancer patients to prevent pain and problems that occur when there has been spread of cancer to the bones. However, these drugs are not approved by Australian heatlh authorities for use in reducing the risk of breast cancer spreading to the bones. For this reason, ZometaTM is considered an investigational drug in this study. There is evidence from earlier studies that bisphosphonates may prevent cancer spreading to the bones. This may be through their effects on bone, which make it more difficult for cancer cells to damage bone. Additionally, very strong bisphosphonates like zoledronic acid may have effects on the cancer cells themselves or help the drugs you are receiving to treat your cancer better. This study was developed by doctors from the United Kingdom and Australia . The overall coordination of the trial is being done by the Clinical Trials and Research Unit at the University of Leeds, UK. The trial is being coordinated in Victoria by the Cancer Council Victoria who seek approximately 300 women to take part throughout Australia. Approximately 3,300 women will take part in this study internationally, half of the women who take part will have the standard treatment that is normally given to treat breast cancer (this half are known as the “control group”), and the other half will have standard treatment plus zoledronic acid. Women who choose to enter this trial may have treatments for 5 years and progress assessments for 10 years.
Interventions
For patients allocated to the investigational arm, zoledronic acid will be given intravenously at a dose of 4mg per treatment. The treatment schedule is every 3-4 weeks for the first 6 months with any chemotherapy, then 3 monthly for 2 years then 5 x 6 monthly infusions. Followup will continue for 5 years after the 5 year treatment period.
Sponsors
Prof Robert Coleman, The University of Sheffield, United Kingdom
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with Stage II/III primary breast cancer - Receiving or scheduled to receive neoadjuvant or adjuvant chemotherapy and/or endocrine therapy- Performance status Eastern Cooperative Oncology Group 0 or 1- Reliable and appropriate contraception. Patient must have given written informed consent prior to study specific procedures.
Exclusion criteria
Metastatic or recurrent breast cancer or a history of breast cancer (excluding ductal carcinoma in situ or lobular carcinoma in situ)- History of prior cancers within the preceding five years (including previous contralateral breast cancer)- History of diseases with influence on bone metabolism such as Paget's disease of the bone, primary hypothyroidism or osteoporosis requiring treatment at the time of study entry or within 6 months- Prior treatment with bisphosphonates within the past year- Serum creatinine > 1.5 x upper limit of normal- Known hypersensitivity to bisphosphonates- Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw- Recent (within 4 weeks of study entry) or planned dental or jaw surgery (eg extractions, implants)- Pregnancy or breast feeding.
Outcome results
None listed