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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01816594
Eligibility Criteria:
Inclusion Criteria:
* Patient had provided a signed study ICF prior to any screening procedure
* Patient was a female ≥ 18 years of age
* Patient has an ECOG performance status of 0-1
* Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer \>2cm by clinical examination and/or \>1.5 cm confirmed by ultrasound or by MRI
* Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status
* Patient has adequate bone marrow, renal and liver function
* Patient is able to swallow and retain oral medication
Exclusion Criteria:
* Patient has received prior systemic treatment for currently diagnosed disease
* Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
* Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
* LVEF below 50% as determined by MUGA scan or ECHO
* Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
* Patient is currently receiving warfarin or other coumarin derived anti-coagulants
* Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
* Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A
* Patient has certain scores on an anxiety and depression mood questionnaires
* Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01816594
Study Brief:
Protocol Section:
NCT01816594