Testing a New Imaging Agent to Identify Cancer
Primary Purpose
HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
89Zr-ss-pertuzumab PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for HER-2 Positive Malignant Carcinoma of Breast focused on measuring HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy, Zr-ss-Pertuzumab
Eligibility Criteria
Inclusion Criteria:
- Biopsy proven HER2-positive primary malignancy or metastatic disease
Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing
- Biopsy proven metastatic disease
- At least five malignant lesions on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- Age 18 years or greater
- ECOG performance of 0-2
Exclusion Criteria:
- Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
- AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
- Life expectancy < 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
Sites / Locations
- PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HER2-positive malignancy
HER2-low malignancy
Arm Description
Participants will have a diagnosis of HER2-positive malignancy
Participants will have a diagnosis of HER2-low malignancy
Outcomes
Primary Outcome Measures
Evaluate clinical safety of 89Zr-ss-pertuzumab
CTCAE Version 5 will be utilized for toxicity evaluation
Secondary Outcome Measures
Full Information
NCT ID
NCT04692831
First Posted
December 30, 2020
Last Updated
August 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04692831
Brief Title
Testing a New Imaging Agent to Identify Cancer
Official Title
Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
Keywords
HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy, Zr-ss-Pertuzumab
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HER2-positive malignancy
Arm Type
Experimental
Arm Description
Participants will have a diagnosis of HER2-positive malignancy
Arm Title
HER2-low malignancy
Arm Type
Experimental
Arm Description
Participants will have a diagnosis of HER2-low malignancy
Intervention Type
Combination Product
Intervention Name(s)
89Zr-ss-pertuzumab PET/CT
Intervention Description
Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.
Primary Outcome Measure Information:
Title
Evaluate clinical safety of 89Zr-ss-pertuzumab
Description
CTCAE Version 5 will be utilized for toxicity evaluation
Time Frame
Up to 20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease
Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH.
Biopsy proven primary malignancy or metastatic disease
At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
Age 18 years or greater
ECOG performance of 0-2
Exclusion Criteria:
Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
Life expectancy < 3 months
Pregnancy or lactation
Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randy Yeh, MD
Phone
212-639-3776
Email
yehr@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Lewis, PhD
Phone
646-888-3038
Email
lewisj2@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Yeh, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Ulaner, MD, PhD
Phone
949-722-6237
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Yeh, MD
Phone
212-639-3776
First Name & Middle Initial & Last Name & Degree
E.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Testing a New Imaging Agent to Identify Cancer
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