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OpenTrials
Completed

NCT Number: NCT02286843

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

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.

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Key information

Conditions

Breast Cancer Metastases HER2 Positive Breast

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

89Zr-trastuzumab

Radiation

PET/CT Scan

Device

89Zr-pertuzumab

Radiation

Primary outcomes

  1. Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Genentech, Inc.
  • United States Department of Defense

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2014
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.