Breast CancerNCT01081613
Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 89Zr-bevacizumab PET imaging
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ER positive, hormone therapy refractory breast cancer, who are participating in the phase I-II trial with HSP90 inhibitor AUY922
Who may be able to join
- patients with ER positive, hormone therapy refractory breast cancer
- participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for the study with AUY922 are described in protocol CAUY922A2101, Clinical Trials no NCT00526045A.
Who cannot join
- no participation in the phase I-II trial with HSP90 inhibitor AUY922
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Imaging the Effect of HSP90 Inhibitor AUY922 on VEGF by Means of 89Zr-bevacizumab PET
Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.
Read the detailed description
This feasibility study is designed as a side study to the multicenter, international phase I-II trial with 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 (p37, 38). Briefly, a dose-escalation study is performed according to phase I design in adult patients with advanced solid malignancies. 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), on the maximal tolerated dose of AUY922 based on the phase I part of the study. Patients with ER positive, hormone therapy refractory breast cancer, will receive a 89Zr-bevacizumab 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-bevacizumab PET scan will be performed before (baseline) and during treatment with HSP90 inhibitor AUY922, as described below.
A minimum of six patients will be entered to evaluate whether the effect of HSP90 inhibition by AUY922 can be detected with a 89Zr-bevacizumab PET scan
- Conditions
- Breast Cancer
- Being tested
- 89Zr-bevacizumab PET imaging
- Keywords
- heat shock protein, breast cancer, PET imaging, bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-bevacizumab PET imagingOther
Also called 89Zr-bevacizumab
injection 89Zr-bevacizumab and 89 Zr-bevacizumab PET scan
| Study group | Role | What they receive |
|---|---|---|
| AUY922 | Patients with estrogen receptor (ER) positive, hormone therapy refractory breast cancer. Receives: Other: 89Zr-bevacizumab PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89Zr-bevacizumab PET.
Primary endpoint: measurement of decreased VEGF 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.P. Schroder, University Medical Center Groningen
- Investigators
- C.P. Schröder, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081613
- Sponsor's protocol ID
- CAUY922A2101
- Other IDs
- 2008-005752-25, 2008
- Status last verified
- Sep 2012
- First submitted
- 4 Mar 2010
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Effect of HSP90 Inhibitor AUY922 on VEGF by Means of 89Zr-bevacizumab PET
- ClinicalTrials.gov ID
- NCT01081613
- Acronym / sponsor ID
- CAUY922A2101
- Conditions
- Breast Cancer
- Keywords
- heat shock protein, breast cancer, PET imaging, bevacizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.
Detailed description
This feasibility study is designed as a side study to the multicenter, international phase I-II trial with 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 (p37, 38). Briefly, a dose-escalation study is performed according to phase I design in adult patients with advanced solid malignancies. 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), on the maximal tolerated dose of AUY922 based on the phase I part of the study. Patients with ER positive, hormone therapy refractory breast cancer, will receive a 89Zr-bevacizumab 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-bevacizumab PET scan will be performed before (baseline) and during treatment with HSP90 inhibitor AUY922, as described below.
A minimum of six patients will be entered to evaluate whether the effect of HSP90 inhibition by AUY922 can be detected with a 89Zr-bevacizumab PET scan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 | – | Other: 89Zr-bevacizumab PET imagingPatients with estrogen receptor (ER) positive, hormone therapy refractory breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ER positive, hormone therapy refractory breast cancer, who are participating in the phase I-II trial with HSP90 inhibitor AUY922
Key inclusion criteria (2 listed)
- patients with ER positive, hormone therapy refractory breast cancer
- participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for the study with AUY922 are described in protocol CAUY922A2101, Clinical Trials no NCT00526045A.
Key exclusion criteria (1 listed)
- no participation in the phase I-II trial with HSP90 inhibitor AUY922
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-bevacizumab PET imagingAlso: 89Zr-bevacizumabinjection 89Zr-bevacizumab and 89 Zr-bevacizumab PET scan | Other | AUY922 |
Primary outcome
To evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89Zr-bevacizumab PET.
Time frame: 2 years
Primary endpoint: measurement of decreased VEGF 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.P. Schröder, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89Zr-bevacizumab PET. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.