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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT02716792
Eligibility Criteria:
Inclusion Criteria:
* For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
* Metastatic breast cancer with at least one bone metastasis
* Karnofsky index \>/= 60
* Life expectancy \>/= 6 months
* Estimated creatinine clearance (Cockcroft and Gault formula) \>/= 30 milliliters per minute (mL/min)
Exclusion Criteria:
* Pregnancy or breast feeding participant
* Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
* Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
* Uncontrolled brain metastasis
* Severe or concomitant infection
* Known medical history of systemic disease with renal lesion
* Rapidly progressing renal failure at inclusion
* Uncontrolled cardiac disorder
* Hypercalcaemia (\> 2.7 millimoles per liter \[mmol/L\]), hypocalcaemia (\< 2 mmol/L)
* Participant receiving nephrotoxic chemotherapy
* Participant eligible for haematopoietic stem cell transplantation at inclusion time
* Bisphosphonate therapy in the 3 weeks before randomization
* Known hypersensitivity to ibandronate or other bisphosphonates
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02716792
Study Brief:
Protocol Section:
NCT02716792