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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 PET

Metabolic 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

Page last updated: August 23, 2015

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