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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT03767335
Eligibility Criteria:
Main Inclusion Criteria:
* Histologically confirmed invasive adenocarcinoma of the breast
* Known HER2+ breast cancer
* Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample
* \> 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab
* Radiological documented evidence of progressive disease
* Life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Main Exclusion Criteria:
* Previous treatment with PI3K inhibitors
* Brain metastases untreated, unless treated \> 4 weeks and only if clinically stable and not receiving corticosteroids
* History of clinically significant bowel disease
* ≥ grade 2 diarrhoea
* History of significant, uncontrolled, or active cardiovascular disease
* Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety
* Not controlled diabetes mellitus (glycated haemoglobin \[HbA1c\] \>7%) and fasting plasma glucose \>126 mg/dL
* Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03767335
Study Brief:
Protocol Section:
NCT03767335