Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-06

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testing a New Imaging Agent to Identify Cancer

NCT04692831

HER-2 Positive Malignant Carcinoma of Breast HER-2 Protein Overexpression HER2-positive Metastatic Breast Cancer

ACTIVE_NOT_RECRUITING PHASE1

HER2-PET Imaging in HER2-low Breast Cancers

NCT06732336

Breast Cancer Metastatic

RECRUITING PHASE1/PHASE2

HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC

NCT06830382

Breast Cancer Stage IV HER2-low Breast Cancer Molecular Imaging

RECRUITING

99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

NCT05622240

Breast Cancer

UNKNOWN EARLY_PHASE1

Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

NCT05982626

HER2-positive Breast Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Metastases HER2 Positive Breast

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HER2-targeted PET/CT

Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.

Group Type EXPERIMENTAL

89Zr-trastuzumab

Intervention Type RADIATION

PET/CT scan

Intervention Type DEVICE

89Zr-pertuzumab

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

89Zr-trastuzumab

Intervention Type RADIATION

PET/CT scan

Intervention Type DEVICE

89Zr-pertuzumab

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women age \> 18
* Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.
* 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)
* ECOG performance score of 0-2

Exclusion Criteria

* Life expectancy \< 3months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits
* CNS only disease on recent imaging

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No