Breast Cancer Metastases Clinical Trial
Official title:
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
| NCT number | NCT02286843 |
| Other study ID # | 14-156 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 6, 2014 |
| Est. completion date | June 30, 2020 |
| Verified date | July 2020 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Genentech, Inc., United States Department of Defense |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases | 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". | 3 years |