Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00525759
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00525759
Study Brief:
Protocol Section:
NCT00525759