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Trial record 10 of 18 for:    cu-64

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02226276
Recruitment Status : Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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-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.

Condition or disease Intervention/treatment Phase
Bone Metastases HER2-positive Breast Cancer Liver Metastases Lung Metastases Recurrent Breast Cancer Soft Tissue Metastases Stage IV Breast Cancer Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: computed tomography Biological: trastuzumab Radiation: copper Cu 64-DOTA-trastuzumab Biological: ado-trastuzumab emtansine Other: laboratory biomarker analysis Not Applicable

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 for 1 year after initiation of treatment until disease progression.

After completion of study treatment, patients are followed up for 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 7, 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (copper Cu 64-DOTA-trastuzumab PET)
Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab 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.
Radiation: fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET/CT
Other Names:
  • 18FDG
  • FDG

Procedure: positron emission tomography
Undergo fludeoxyglucose F 18 PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Procedure: computed tomography
Undergo fludeoxyglucose F 18 PET/CT
Other Name: tomography, computed

Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2

Radiation: copper Cu 64-DOTA-trastuzumab
Given IV
Other Name: 64Cu-DOTA-trastuzumab

Procedure: positron emission tomography
Undergo copper Cu-DOTA-trastuzumab PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Biological: ado-trastuzumab emtansine
Given IV
Other Names:
  • Kadcyla
  • T-DM1
  • trastuzumab-DM1
  • trastuzumab-MCC-DM1
  • trastuzumab-MCC-DM1 antibody-drug conjugate

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Tumor uptake of copper Cu 64-DOTA-trastuzumab as measured by PET [ Time Frame: Baseline ]
    Will be correlated with subsequent tumor response to ado-trastuzumab emtansine using a t-test with a 0.05 two-sided significance level.

  2. Metabolic tumor response to ado-trastuzumab emtansine as assessed by fludeoxyglucose F 18 PET/CT [ Time Frame: Up to 1 year ]
    Will be correlated with uptake of copper Cu 64-DOTA-trastuzumab using a t-test with a 0.05 two-sided significance level.

  3. Copper Cu 64-DOTA-trastuzumab uptake metrics [ Time Frame: Baseline ]
    Will be compared between "responding" and "non-responding" tumors using a t-test with 0.05 one-sided significance level.

  4. Presence of putative MMRs to ado-trastuzumab emtansine [ Time Frame: Baseline ]
    Tissue 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 copper Cu 64-DOTA-trastuzumab as measured with PET/CT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226276


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joanne Mortimer City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02226276     History of Changes
Other Study ID Numbers: 14099
NCI-2014-01812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
14099 ( Other Identifier: City of Hope Medical Center )
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antibodies
Immunoconjugates
Trastuzumab
Ado-trastuzumab emtansine
Maytansine
Copper
Fluorodeoxyglucose F18
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals