Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Information source: City of Hope Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bone Metastases; HER2-positive Breast Cancer; Liver Metastases; Lung Metastases; Recurrent Breast Cancer; Soft Tissue Metastases; Stage IV Breast Cancer
Intervention: fludeoxyglucose F 18 (Radiation); positron emission tomography (Procedure); computed tomography (Procedure); trastuzumab (Biological); copper Cu 64-DOTA-trastuzumab (Radiation); positron emission tomography (Procedure); ado-trastuzumab emtansine (Biological); laboratory biomarker analysis (Other)
Phase: N/A
Status: Recruiting
Sponsored by: City of Hope Medical Center Official(s) and/or principal investigator(s): Joanne Mortimer, Principal Investigator, Affiliation: City of Hope Medical Center
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-trastuzumab emtansine in patients with human epidermal growth factor
receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper
Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive
substance. Diagnostic procedures using PET may allow scanners to take pictures of where the
drug travels in the body and may help doctors identify which patients may benefit from
treatment with ado-trastuzumab emtansine.
Clinical Details
Official title: A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Tumor uptake of copper Cu 64-DOTA-trastuzumab as measured by PETMetabolic tumor response to ado-trastuzumab emtansine as assessed by fludeoxyglucose F 18 PET/CT Copper Cu 64-DOTA-trastuzumab uptake metrics Presence of putative MMRs to ado-trastuzumab emtansine
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
serial 18F-fludeoxyglucose (FDG) (fludeoxyglucose F 18)/PET-computed tomography (CT).
II. Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients
who do not respond to ado-trastuzumab emtansine.
III. Obtain tumor tissue for subsequent assessment of the presence of putative molecular
mechanisms of resistance (MMRs) to ado-trastuzumab emtansine. When funding becomes
available, those samples will be used to explore the correlation between the presence of
MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in
univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as
measured with PET/CT.
OUTLINE:
Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab
intravenously (IV) over 15 minutes immediately before receiving copper Cu
64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive
ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at
the discretion of the treating oncologist. Patients undergo restaging by whole body
fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease
progression.
After completion of study treatment, patients are followed up for 1 year.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women with metastatic HER2-positive breast cancers whose disease has progressed on
first-line trastuzumab + chemotherapy will be considered eligible for study
participation if they meet the following criteria:
- 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 within 28 days prior to enrollment; 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
- Planned therapy with ado-trastuzumab emtansine
- 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 Criteria:
- 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
Locations and Contacts
City of Hope Medical Center, Duarte, California 91010, United States; Recruiting Joanne E. Mortimer, MD, Phone: 800-826-4673, Email: jmortimer@coh.org Joanne E. Mortimer, MD, Principal Investigator
Additional Information
Starting date: January 2015
Last updated: May 20, 2015
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