Investigating the Biological Effects of the Addition of Zoledronic Acid to Pre-operative Chemotherapy in Breast Cancer (ANZAC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
There is clear preclinical in vitro and in vivo evidence of sequence dependent synergy between chemotherapy agents and zoledronic acid. The aim of the study is to investigate if the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in patients. The hypothesis for this study is that there may be anti-tumour benefits of the sequential application of chemotherapy agents followed by zoledronic acid in patients with invasive breast cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Women with histological diagnosis of invasive breast cancer requiring neoadjuvant chemotherapy
- T2 tumour or above
- WHO Performance status of 0,1 or 2
- Must consent to or have undergone a core biopsy for diagnosis of breast cancer AND consent to undergo an additional core biopsy prior to the second cycle of chemotherapy (Day 5 +/- Day 21)
- Written informed consent
Exclusion criteria
- Previous chemotherapy or radiotherapy to treated breast
- Evidence of metastatic disease or recurrent breast cancer or previous malignancy (some exceptions)
- Calculated creatinine clearance < 40mls/min
- Prior treatment with bisphosphonates in last year or known contraindications to bisphosphonate therapy
- Concurrent tamoxifen or aromatase inhibitor medication
- Pregnant or lactating women
- Cardiac dysfunction that precludes use of anthracycline chemotherapy
- Unwilling to have extra interim biopsy
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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