A clinical study to investigate the safety and efficacy of theinvestigational compound AUY922 when combined with trastuzumab inpatients with advanced HER2-positive breast cancer who haveprogressed on prior trastuzumab treatment.

Active, not recruiting

• Conditions: female patients with HER2-positive, locally advanced, recurrent ormetastatic breast cancerafter failure of Trastuzumab treatment who received at least 1 but nomore than 2 prior anti-HER2-based regimens including at least 1 Trastuzumab containingregimen.; MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-015628-27-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-13
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Female pts with confirmed HER2-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

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 exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified