Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

NCT01093612 | Active Not Recruiting Results DMC

• 3 other identifiers: 09101NCI-2010-00322BC095002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Stage IV Breast Cancer

Keywords

HER2-positive breast cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Procedure: positron emission tomography; Radiation: copper Cu 64-DOTA-trastuzumab; Procedure: Biopsy; Other: Immunohistochemistry staining method; Other: laboratory biomarker analysis; Genetic: mutation analysis

Interventions

positron emission tomography PROCEDURE

PET images performed on a GE Discovery 16 Ste PET-CT scanner

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Arm I

copper Cu 64-DOTA-trastuzumab RADIATION

15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.

Also known as: 64Cu-DOTA-trastuzumab

Arm I

Biopsy PROCEDURE

Correlative Studies

Also known as: biopsies

Arm I

Immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

mutation analysis GENETIC

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; 64Cu-DOTA-trastuzumab; Biopsy; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Histocytochemistry; Histological Techniques; Immunologic Techniques

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Joanne Mortimer

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 26, 2010
• Study Start: March 16, 2011
• Primary Completion: October 23, 2018
• Study Completion (Estimated): September 8, 2026
• Last Updated: November 14, 2025
• Results First Posted: March 28, 2023

Record last verified: 2025-11

Locations

US (1)