Does zoledronic acid alter levels of reproductive hormones and how does this affect the tumour and bone in pre- and post-menopausal women with early breast cancer?
- Conditions
- Breast CancerCancer
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 19
1. Female patients aged = 40
2. Histologically confirmed early breast cancer
3. Tumour size more than 1cm (= 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum follistatin measured by ELISA using validated lab kits at day 28 post-ZOL administration.
- Secondary Outcome Measures
Name Time Method 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:<br>1. Change in serum follistatin measured by ELISA using validated lab kits at day 7 and 28 post-ZOL infusion <br>2. Change in serum activin measured by ELISA using validated lab kits at day 7 and day 28 post-ZOL infusion<br>3. Change in serum follistatin measured by ELISA using validated lab kits from day 0 (surgery) to day 21 and day 28 post-surgery <br>4. Change in serum activin measured by ELISA using validated lab kits from day 0 (surgery) to day 21 and day 28 post-surgery <br>5. Follistatin and activin levels measured by ELISA using validated lab kits in tumour samples obtained at surgery