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Trial record 14 of 18 for:    cu-64

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 1, 2019
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 26, 2010
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE March 14, 2011
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • 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 ]
Change History Complete list of historical versions of study NCT01093612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
Official Title  ICMJE 64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Cancer
  • Stage IV Breast Cancer
Intervention  ICMJE
  • Procedure: positron emission tomography
    PET images performed on a GE Discovery 16 Ste PET-CT scanner
    Other Names:
    • FDG-PET
    • PET
    • PET scan
    • tomography, emission computed
  • Radiation: copper Cu 64-DOTA-trastuzumab
    15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
    Other Name: 64Cu-DOTA-trastuzumab
  • Procedure: Biopsy
    Correlative Studies
    Other Name: biopsies
  • Other: Immunohistochemistry staining method
    Correlative studies
    Other Name: immunohistochemistry
  • Other: laboratory biomarker analysis
    Correlative studies
  • Genetic: mutation analysis
    Correlative studies
Study Arms  ICMJE 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.
Interventions:
  • Procedure: positron emission tomography
  • Radiation: copper Cu 64-DOTA-trastuzumab
  • Procedure: Biopsy
  • Other: Immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Genetic: mutation analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
30
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility Part I (Determination of the cold dose)

  • Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
  • At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
  • The cancer must over express HER2 as determined by IHC and FISH.
  • Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
  • Participants must have normal cardiac ejection fraction.

Eligibility Part 2 (correlation of HER2 expression with PET uptake)

  • Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
  • At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
  • Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
  • Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
  • Participants must have normal cardiac ejection fraction.

Ineligibility

  • Participants who have received trastuzumab within the prior 2 months
  • Participants who are not considered candidates for trastuzumab
  • Metastatic disease in a single site
  • No metastatic site greater than or equal to 2 cm
  • Concurrent malignancy other than skin cancer
  • Inability to provide informed consent
  • Participants who are pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01093612
Other Study ID Numbers  ICMJE 09101
NCI-2010-00322 ( Registry Identifier: NCI CTRP )
BC095002 ( Other Grant/Funding Number: Department of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joanne Mortimer City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP