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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT01271920
Eligibility Criteria:
Inclusion Criteria:
* Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer
* All patients must have received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab.
* All patients must have at least one measurable lesion as defined by RECIST criteria.
* All patients must have documented progressive disease following the last line of therapy before entering the study
* ECOG Performance status ≤ 1
Exclusion Criteria:
* Patients with known CNS metastasis which are: symptomatic or require treatment for symptom control and/or growing
* Prior treatment with any HSP90 or HDAC inhibitor
* Impaired cardiac function
* Acute or chronic liver or renal disease
* Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922
* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01271920
Study Brief:
Protocol Section:
NCT01271920