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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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

C.P. Schröder, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

27112008 version 1

NCT ID:

NCT01081600

Start Date:

February 2010

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Heat shock protein
  • breast cancer
  • PET imaging
  • trastuzumab
  • Breast Neoplasms

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