What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving trastuzumab and ado-trastuzumab emtansine, can cause side effects such as diarrhea, fatigue, and stomatitis. Ado-trastuzumab emtansine may also lead to additional chemotherapy-related toxicities like nausea, fatigue, hair loss, and increased infection risk. Endocrine therapies, such as tamoxifen and aromatase inhibitors, often result in hot flashes, bone density loss, and cardiovascular risks.

What prior FDA approvals exist?

The FDA has approved several treatments for HER2-positive breast cancer, which is the focus of the Copper Cu 64-DOTA-trastuzumab PET trial. Trastuzumab (Herceptin) is a monoclonal antibody that targets the HER2 receptor and has been a cornerstone in treating HER2-positive breast cancer. Ado-trastuzumab emtansine (Kadcyla) is an antibody-drug conjugate combining trastuzumab with the cytotoxic agent emtansine, allowing targeted delivery of chemotherapy to HER2-positive cancer cells. These treatments have significantly improved outcomes for patients with HER2-positive breast cancer.

What other types of research exist?

Promising alternatives to Copper Cu 64-DOTA-trastuzumab PET for breast cancer patients include 64Cu-labeled affibody molecules, such as 64Cu-DOTA-Z(HER2:477), which have shown good and specific tumor localization in HER2-expressing tumors. Additionally, 64Cu-NOTA-TRC105-800CW, which targets CD105 expression during tumor angiogenesis, could be considered for its specificity and persistent uptake in tumors.

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Monoclonal Antibodies

Copper Cu 64-DOTA-Trastuzumab PET for HER2 Positive Breast Cancer

N/A

Waitlist Available

Led By Joanne Mortimer

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special scan to track a drug in patients with advanced HER2 positive breast cancer. The scan helps predict if the treatment will be effective by showing how much of the drug reaches the tumors. Patients are then treated with a specific cancer drug.

Who is the study for?

This trial is for women with HER2 positive metastatic breast cancer that has spread to the lung, liver, soft-tissue or bone. Participants must be able to consent, have a performance status of 0-2, a recent biopsy confirming HER2 positivity without subsequent HER2 therapy, normal heart function and at least one large enough metastasis. Pregnant women and those who've had trastuzumab within 6 weeks are excluded.

What is being tested?

The study tests if Copper Cu 64-DOTA-trastuzumab PET scans can predict the effectiveness of ado-trastuzumab emtansine treatment in patients. It involves attaching a radioactive substance to chemotherapy drug trastuzumab and using PET scans to track its movement in the body.

What are the potential side effects?

Potential side effects include reactions related to radioactivity exposure from PET scans such as nausea or allergic reactions, as well as typical chemotherapy-related issues like fatigue, lowered blood cell counts leading to increased infection risk, heart problems and possible organ damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (copper Cu 64-DOTA-trastuzumab PET)Experimental Treatment7 Interventions

Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

positron emission tomography

2010

Completed Phase 2

~1370

ado-trastuzumab emtansine

2014

Completed Phase 1

~20

trastuzumab

2002

Completed Phase 3

~1790

fludeoxyglucose F 18

2005

Completed Phase 3

~3970

computed tomography

2010

Completed Phase 2

~1200

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

HER2-targeted therapies, such as trastuzumab and ado-trastuzumab emtansine, are designed to treat HER2-positive breast cancer by targeting the HER2 protein on cancer cells. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor, inhibiting cell proliferation and marking the cells for destruction by the immune system. Ado-trastuzumab emtansine combines trastuzumab with a chemotherapy drug, delivering the cytotoxic agent directly to the cancer cells, thereby increasing the treatment's efficacy while minimizing systemic side effects. These targeted approaches are significant for patients as they offer more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

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