What side effects are associated with this type of intervention?

Common treatments for HER2-positive breast cancer include anti-HER2 therapies such as trastuzumab, pertuzumab, and trastuzumab-emtansine (T-DM1). These treatments can cause side effects like cardiac events (e.g., decreased left ventricular ejection fraction), fatigue, nausea, diarrhea, and interstitial lung disease. Chemotherapy agents used in combination with these therapies may lead to additional side effects such as neutropenia, anemia, and gastrointestinal symptoms. Monitoring and managing these side effects are crucial for patient care.

What prior FDA approvals exist?

Several FDA-approved treatments target HER2-positive breast cancer. Trastuzumab (Herceptin) is a monoclonal antibody that targets the HER2 receptor and has been a cornerstone in the treatment of HER2-positive breast cancer. Pertuzumab (Perjeta) is another monoclonal antibody that, when combined with trastuzumab and chemotherapy, has shown improved outcomes. Trastuzumab emtansine (T-DM1, Kadcyla) is an antibody-drug conjugate that combines trastuzumab with a cytotoxic agent. More recently, trastuzumab deruxtecan (Enhertu) has been approved for patients who have previously received other anti-HER2 therapies. Additionally, tucatinib, in combination with trastuzumab and capecitabine, has been approved for advanced HER2-positive breast cancer, including cases with brain metastases.

What other types of research exist?

Promising alternatives to [18F]GEH121224 for PET imaging of HER2 positive breast cancer include [68Ga]-NOTA-2Rs15d, which has shown high-specific-contrast imaging of HER2-positive tumors with no observed toxicity in preclinical validation, and [64Cu]Cu-NOTA-Bn-GE11, which targets EGFR-rich tumors and may benefit patients with HER2-positive breast cancer due to the overlap in therapeutic targets.

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[18F]GEH121224 Imaging for Advanced Breast Cancer (HER2-1 Trial)

Phase 1

Waitlist Available

Research Sponsored by GE Healthcare

Eligibility Criteria Checklist

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

Must have

Previously received no more than 1 prior lines of systemic chemotherapy (including anti HER2 therapy) for metastatic breast cancer

Target lesion diameter of ≥15 mm that has not been previously treated with radiotherapy

Must not have

Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Systemic therapy including anti-HER2 therapy within 2 weeks before enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging substance called [18F]GEH121224 in female patients with advanced HER2-positive breast cancer. The substance helps highlight cancer cells during a PET scan, making them easier to detect and study.

Who is the study for?

This trial is for women over 18 with advanced HER2-positive breast cancer who've had no more than one chemotherapy treatment. They must be willing to follow study rules, not be pregnant or breastfeeding, and use contraception post-injection. Participants need good organ function and a life expectancy over three months.

What is being tested?

[18F]GEH121224 is being tested as a PET scan tracer for detecting HER2 in breast cancer. The Phase 1 trial involves two small groups of patients: one for dosimetry studies and another for test-retest reliability, assessing the tracer's safety and pharmacokinetics.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include reactions related to the injection of [18F]GEH121224 or discomfort from undergoing PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had only one chemotherapy treatment for my breast cancer that has spread.

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My cancer has a large lesion that hasn't been treated with radiation.

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My breast cancer has spread beyond the initial area.

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My breast cancer is advanced or has spread, and a recent test confirmed it's HER2 positive.

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Your blood and organ function levels need to be within normal ranges. This means your hemoglobin, white blood cell count, platelet count, and other tests need to be at certain levels.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe side effects from past cancer treatments.

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I haven't had any systemic or anti-HER2 therapy in the last 2 weeks.

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I have ongoing hepatitis B or C.

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I have a history of heart disease.

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I do not have a current history of drug or alcohol abuse or any active liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of [18F]GEH121224

Change in injection site status following administration of [18F]GEH121224

Changes in blood pressure in mmHg following administration of [18F]GEH121224

+4 more

Secondary study objectives

Biodistribution

Reproducibility

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: [18F]GEH121224 - Group 2 - ReproducibilityExperimental Treatment2 Interventions

Group II: [18F]GEH121224 - Group 1 - BiodistributionExperimental Treatment2 Interventions

0 / 12Eligibility criteria met

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

Common treatments for HER2-positive breast cancer include targeted therapies such as trastuzumab and pertuzumab, which are monoclonal antibodies that bind to the HER2 receptor, blocking its signaling and inhibiting tumor growth. Diagnostic imaging agents like [18F]GEH121224 are used to detect HER2 expression, allowing for precise monitoring and tailoring of treatment. This targeted approach is essential for enhancing treatment effectiveness and improving patient outcomes.

Phase II Feasibility and Biomarker Study of Neoadjuvant Trastuzumab and Pertuzumab With Chemoradiotherapy for Resectable Human Epidermal Growth Factor Receptor 2-Positive Esophageal Adenocarcinoma: TRAP Study.Correlation of breast cancer subtypes, based on estrogen receptor, progesterone receptor, and HER2, with functional imaging parameters from ⁶⁸Ga-RGD PET/CT and ¹⁸F-FDG PET/CT.Positron emission tomography imaging with 18F-labeled ZHER2:2891 affibody for detection of HER2 expression and pharmacodynamic response to HER2-modulating therapies.