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89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition (AUY922)

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ClinicalTrials.gov Identifier: NCT01081600
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
C.P. Schroder, University Medical Centre Groningen

Brief Summary:

HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging. Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%, quantified 6 days after the last administration of AUY922.

Visualizing HER2 expression in breast cancer patients before and early following HSP90 inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.


Condition or disease Intervention/treatment
Breast Cancer Other: Imaging with 89Zr-trastuzumab PET

Detailed Description:

This study is designed as a side study to the multicenter, international phase I-II trial with the HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p36, 37). Briefly, a dose-escalation study is performed according to phase I design. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients). Patients with HER2 positive, trastuzumab refractory breast cancer, will receive a 89Zr-trastuzumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).

To this end, a 89Zr-trastuzumab PET scan will be performed before (baseline) and during treatment with the HSP90 inhibitor AUY922, as described below.

A minimum of six patients are needed to evaluate whether the 89Zr-trastuzumab PET scan can be used for the detection of a decrease of HER2 expression, induced by HSP90 inhibition.


Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging the Effect of HSP90 Inhibitor AUY922 on HER2 Expression by Means of 89Zr-trastuzumab PET. Side Study to Phase I-II Study With AUY922 in Either HER2 or ER Positive Locally Advanced or Metastatic Breast Cancer: Protocol CAUY922A2101
Study Start Date : February 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
AUY922
Patients with HER2 positive breast cancer which has become trastuzumab resistent.
Other: Imaging with 89Zr-trastuzumab PET
Injection with 89Zr-trastuzumab and 89Zr-trastuzumab PET scan.
Other Name: 89Zr-trastuzumab



Primary Outcome Measures :
  1. To show the effect of the HSP90 inhibitor AUY922 on HER2 expression by means of 89Zr-trastuzumab PET scanning. [ Time Frame: 2 years ]
    Primary endpoint: measurement of decreased HER2 expression compared to baseline. A decline is defined as a decrease of at least 30% in mean Standardized Uptake Value (SUV) in a maximum of three lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HER2 positive breast cancer which has become trastuzumab resistent, who are participating in the phase I-II trial with HSP90 inhibitor AUY922
Criteria

Inclusion Criteria:

  • Patients with HER2 positive, trastuzumab (and lapatinib) refractory breast cancer
  • Participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for this study with AUY922 are described in protocol CAUY922A2101.

Exclusion Criteria:

  • No participation in the phase I-II trial with HSP90 inhibitor AUY922 (CAUY922A2101. Clinical trials no. NCT00526045A)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081600


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: C.P. Schröder, PhD University Medical Center Groningen

Responsible Party: C.P. Schroder, Principal investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01081600     History of Changes
Other Study ID Numbers: 27112008 version 1
2008-005751-26 ( EudraCT Number )
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by C.P. Schroder, University Medical Centre Groningen:
Heat shock protein
breast cancer
PET imaging
trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents