Breast Cancer Cancer Breast cancer
Conditions
Interventions
Participants in both arms receive a single intravenous infusion of zoledronic acid 4mg in 100ml 0.9% sodium chloride over 15 minutes on either day seven pre-surgery or day 21 post-surgery. The purpos
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged =40 years 2. Histologically confirmed early breast cancer 3. Tumour size more than 1 cm (= T1) 4. Any nodal status including unknown (=N0) 5. Scheduled for surgery as primary treatment 6. Any tumour hormone receptor (ER/PR) or HER2 status 7. ECOG performance status of 0, 1 or 2 (appendix 2) 8. Menopausal status defined clinically by menstrual and clinical history, or where this is indeterminate patient is willing to have biochemical profile testing following consent 9. Measured or calculated Glomerular Filtration Rate (GFR) =30 ml/min (Cockcroft and Gault formula, appendix 3) 10. Serum corrected calcium =2.2mmol/L 11. APTT ?30.5 seconds 12. PT ?13.2 seconds or INR <1.5 13. Platelets ?100 x 109/L 14. Or clotting abnormalities which are due to be reversed as part of standard care by the time of bone marrow sampling (e.g. stopping anticoagulants prior to surgery) 15. Potentially fertile women must have a negative pregnancy test within 72 hours prior to randomisation, and not be breast-feeding 16. Potentially fertile women must agree to use effective, medically approved, barrier contraception from the time of consent to 30 days after their zoledronic acid infusion 17. Potential participants must be willing to have the required mandatory samples taken, including bone marrow aspiration and trephine at the time of surgery 18. Potential participants must have the mental capacity to understand the study information, make an informed choice regarding participation and to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Any previous diagnosis or treatment of cancer that could confound results and endpoints (allowed situations include non-melanomatous skin cancer or superficial bladder cancer) 2. Patients with an estimated life expectancy of <6 months 3. Any diagnosis of a bone marrow disorder 4. Any previous bisphosphonate treatment 5. Use of hormone replacement therapy (HRT) in the past 30 days or a diagnosis of hormonal imbalance such as polycystic ovarian syndrome 6. Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), any open oral wounds or a current or previous diagnosis of osteonecrosis of the jaw 7. Recent (within 4 weeks) or planned dental or jaw surgery (recent dental fillings, scaling, polishing or minor gingival surgery do not exclude the patient) 8. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the ZOLMENO study, including dehydration, notable electrolyte disturbances, significant use of nephrotoxic, antiangiogenic or hypocalcaemia inducing drugs or history of significant renal failure, which in the opinion of the screening investigator, would render the patient unsuitable for zoledronic acid or sample collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum follistatin measured by ELISA using validated lab kits at day 28 post-ZOL administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures, all compared relative to menopausal status (pre- vs. post-menopausal) and timing of ZOL administration (Group A vs. Group B), includes: 1. Change in serum follistatin measured by ELISA using validated lab kits at day 7 and 28 post-ZOL infusion 2. Change in serum activin measured by ELISA using validated lab kits at day 7 and day 28 post-ZOL infusion 3. Change in serum follistatin measured by ELISA using validated lab kits from day 0 (surgery) to day 21 and day 28 post-surgery 4. Change in serum activin measured by ELISA using validated lab kits from day 0 (surgery) to day 21 and day 28 post-surgery 5. Follistatin and activin levels measured by ELISA using validated lab kits in tumour samples obtained at surgery | — |
Countries
England, United Kingdom
Contacts
Public ContactErica Wallis
Outcome results
None listed