Trial Information

A Study to Determine Alteration of Anti-mullerian Hormone (AMH) Concentrations in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer

Type of Study: Translational Study

Sample Type: A 10mL blood sample will be collected in red vacutainer tubes (no
anticoagulant, no gel) from each patient at the designated time points +/- 7days. Blood
should preferably be collected in the follicular phase of the menstrual cycle.

Time of Sample procurement:

- 1st Sample: Pre-Chemotherapy (≤ 14 days pre-treatment)

- 2nd Sample: e.g. before cycle 3, if undergoing a 4 cycle regimen or before cycle 4 in a
6 cycle regimen. (If the chemotherapy regimen changes following the commencement of
chemotherapy &/or after surgery, then blood samples will be taken at the time points
determined by the original plan i.e. if a patient was to have 6 cycles of chemotherapy
and this was then changed to 4 cycles samples will be taken before cycle 4)

- 3rd sample: 3 weeks following the last dose of chemotherapy

- 4th sample: 3 months following the last dose of chemotherapy

- 5th sample: 6 months following the last dose of chemotherapy

- 6th sample: 1 year following the last dose of chemotherapy

- 7th sample: 2 years following the last dose of chemotherapy

- 8th sample: 3 years following the last dose of chemotherapy

Patient's menstrual status including the commencement date of last menstrual period or the
use of Intra Uterine Devices (IUD) and FSH, LH and E2 levels will be documented on the
Baseline Assessment CRF.

FSH, LH and E2 levels will also be measured at each time point and documented on the
Follow-up Assessment CRF.