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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00322 | Registry Identifier | NCI CTRP | |
| BC095002 | Other Grant/Funding Number | Department of Defense |
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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.
PRIMARY OBJECTIVES:
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.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography | Procedure | PET images performed on a GE Discovery 16 Ste PET-CT scanner |
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours | Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). | 24 hours after injection of 64 CU-DOTA-trastuzumab |
| Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours | Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). | 48 hours after injection of 64 CU-DOTA-trastuzumab |
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Eligibility Part I (Determination of the cold dose)
Eligibility Part 2 (correlation of HER2 expression with PET uptake)
Ineligibility
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Mortimer | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HER2+ Patients | HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. |
| FG001 | HER2- Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2013 |
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| copper Cu 64-DOTA-trastuzumab | Radiation | 15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg. |
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| Biopsy | Procedure | Correlative Studies |
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| Immunohistochemistry staining method | Other | Correlative studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| mutation analysis | Genetic | Correlative studies |
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HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HER2+ Patients | HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. |
| BG001 | HER2- Patients | HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours | Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). | Posted | Median | Inter-Quartile Range | SUVmax (g/mL) | 24 hours after injection of 64 CU-DOTA-trastuzumab |
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| Primary | Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours | Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). | Posted | Median | Inter-Quartile Range | SUVmax (g/mL) | 48 hours after injection of 64 CU-DOTA-trastuzumab |
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Adverse events were collected over a period of 2 years and 9 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HER2+ Patients | HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | HER2- Patients | HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax. | 0 | 7 | 0 | 7 | 0 | 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Mar 2, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| C546788 | 64Cu-DOTA-trastuzumab |
| D001706 | Biopsy |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
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| Male |
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| African American |
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| Hispanic |
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| Native American |
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| White Non-Hispanic |
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| Participants |
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