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

Not Applicable

Completed

• Conditions: Breast Cancer Metastases; HER2 Positive Breast

• Registration Number: NCT02286843
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Results First Submitted: 2021-05-25
• Results First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Results First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases	3 years	Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States