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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03244358
Eligibility Criteria:
Inclusion Criteria:
* Female ≥ 18 years, ≤70 years.
* Minimum life expectancy 16 weeks
* Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
* Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
* ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease
* Adequate bone marrow and organ function
* Availability of archival tumour sample or fresh biopsy Informed consent
* Normal organ function
Exclusion Criteria:
* Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation \<21 days prior to study treatment
* Last dose of palliative radiotherapy \<7 days prior to study treatment
* Rapidly progressive visceral disease not suitable for further therapy
* Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
* Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
* Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
* Elevated ALP in absence of bone metastasis
* Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
* Participation in another study with investigational product during last 30 days
* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03244358
Study Brief:
Protocol Section:
NCT03244358