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

NCT01081600 | Completed DMC

• 2 other identifiers: 27112008 version 12008-005751-26
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Heat shock protein; breast cancer; PET imaging; trastuzumab

Outcome Measures

Primary Outcomes (1)

• To show the effect of the HSP90 inhibitor AUY922 on HER2 expression by means of 89Zr-trastuzumab PET scanning.

  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.

  2 years

Study Arms (1)

AUY922

Patients with HER2 positive breast cancer which has become trastuzumab resistent.

Other: Imaging with 89Zr-trastuzumab PET

Interventions

Imaging with 89Zr-trastuzumab PET OTHER

Injection with 89Zr-trastuzumab and 89Zr-trastuzumab PET scan.

Also known as: 89Zr-trastuzumab

AUY922

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with HER2 positive, trastuzumab (and lapatinib) refractory breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

X-Rays; zirconium-89-trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• C.P. Schröder, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

NL (1)