A clinical study to investigate the safety and efficacy of the investigational compound AUY922 when combined with trastuzumab in patients with advanced HER2-positive breast cancer who have progressed on prior trastuzumab treatment.
- Conditions
- female patients with HER2-positive, locally advanced, recurrent or metastatic breast cancer after failure of Trastuzumab treatment who received at least 1 but no more than 2 prior anti- HER2-based regimens including at least 1 Trastuzumab containing regimen.MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-015628-27-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
- Female patients with confirmed HER-2 positive, non-operable locally advanced or metastatic breast cancer
- 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
Other protocol-defined inclusion criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
- 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 exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method