Status:
ACTIVE_NOT_RECRUITING
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bone Metastases
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado...
Detailed Description
PRIMARY OBJECTIVES: I. Correlate uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by se...
Eligibility Criteria
Inclusion
- Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained prior to initiation of chemotherapy; it should be performed within 28 days prior to enrollment (patients with a biopsy of recurrent disease that is HER2-positive and have not received HER2-directed therapy since the biopsy can exceed the 28-day window up to 6 months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
- At least 1 site of metastasis \>= 20 mm in mean diameter must be identified
- The cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
- Patients may not have received trastuzumab within 6 weeks of projected 64Cu-DOTA-trastuzumab/PET-CT
- Participants must have normal cardiac ejection fraction
- Ability to provide informed consent
- Patients that may need dose reduction to commence cycle 1 treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Negative serum pregnancy test (female of childbearing potential only)
- Patients must have adequate cardiac function; left ventricular ejection fraction (LVEF) \>= 50% as determined by multi gated acquisition (MUGA) scan or echocardiogram
Exclusion
- Participants who have received trastuzumab within the prior 36 days
- Participants who are not considered candidates for ado-trastuzumab-emtansine
- No metastatic sites \>= 20 mm
- Concurrent malignancy other than skin cancer - Inability to provide informed consent
Key Trial Info
Start Date :
January 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02226276
Start Date
January 7 2015
End Date
October 30 2025
Last Update
February 18 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010