PET Scan with Copper Cu 64-DOTA-Trastuzumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Joanne Mortimer

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joanne Mortimer

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women with advanced HER2-positive breast cancer that has spread beyond the original tumor and axilla. They must have a biopsy confirming metastasis, not received trastuzumab in the last 2 months, and have at least one non-liver metastatic site over 2 cm. Participants need normal heart function and can't be pregnant or unable to consent.

Inclusion Criteria

I am a woman with breast cancer that has spread beyond the original area and underarm.

I have a cancer spread larger than 2 cm outside my liver.

My heart pumps blood normally.

Exclusion Criteria

I have another type of cancer besides skin cancer.

Participants who are pregnant

Inability to provide informed consent

Treatment Details

Interventions

• copper Cu 64-DOTA-trastuzumab (Monoclonal Antibodies)
• positron emission tomography (Procedure)

Trial Overview The study tests a PET scan using copper Cu 64-DOTA-trastuzumab to see if it helps plan better treatments for breast cancer. It includes laboratory biomarker analysis, immunohistochemistry staining method, mutation analysis, and biopsies to assess the cancer's characteristics.

Participant Groups

Group I: Arm I Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD