Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01093612|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2010
Last Update Posted : May 8, 2018
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment
PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage IV Breast Cancer||Procedure: positron emission tomography Radiation: copper Cu 64-DOTA-trastuzumab Procedure: Biopsy Other: Immunohistochemistry staining method Other: laboratory biomarker analysis Genetic: mutation analysis||Not Applicable|
I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer|
|Study Start Date :||March 14, 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Arm I
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
Procedure: positron emission tomography
PET images performed on a GE Discovery 16 Ste PET-CT scanner
Other Names:Radiation: copper Cu 64-DOTA-trastuzumab
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Other Name: 64Cu-DOTA-trastuzumabProcedure: Biopsy
Other Name: biopsiesOther: Immunohistochemistry staining method
Other Name: immunohistochemistryOther: laboratory biomarker analysis
Correlative studiesGenetic: mutation analysis
- Dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ]
- Correlation of tumor uptake on 64Cu-DOTA-trastuzumab PET with tumor expression of HER2 [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ]
- Relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ]Peak SUV will be plotted against HER2+ status.
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): NCT01093612
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Joanne Mortimer||City of Hope Medical Center|