Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01093612
First received: March 23, 2010
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment

PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.


Condition Intervention
Breast Cancer
Stage IV Breast Cancer
Procedure: positron emission tomography
Radiation: copper Cu 64-DOTA-trastuzumab
Procedure: Biopsy
Other: Immunohistochemistry staining method
Other: laboratory biomarker analysis
Genetic: mutation analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ] [ Designated as safety issue: No ]
  • Correlation of tumor uptake on 64Cu-DOTA-trastuzumab PET with tumor expression of HER2 [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ] [ Designated as safety issue: No ]
  • Relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway [ Time Frame: 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab ] [ Designated as safety issue: No ]
    Peak SUV will be plotted against HER2+ status.


Enrollment: 18
Study Start Date: March 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
Procedure: positron emission tomography
PET images performed on a GE Discovery 16 Ste PET-CT scanner
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Radiation: copper Cu 64-DOTA-trastuzumab
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Other Name: 64Cu-DOTA-trastuzumab
Procedure: Biopsy
Correlative Studies
Other Name: biopsies
Other: Immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: laboratory biomarker analysis
Correlative studies
Genetic: mutation analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.

II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.

III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.

OUTLINE:

This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Part I (Determination of the cold dose)

  • 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 study. 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 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
  • The cancer must over express HER2 as determined by IHC and FISH.
  • Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
  • Participants must have normal cardiac ejection fraction.

Eligibility Part 2 (correlation of HER2 expression with PET uptake)

  • 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 study. 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 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
  • Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
  • Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
  • Participants must have normal cardiac ejection fraction.

Ineligibility

  • Participants who have received trastuzumab within the prior 2 months
  • Participants who are not considered candidates for trastuzumab
  • Metastatic disease in a single site
  • No metastatic site greater than or equal to 2 cm
  • Concurrent malignancy other than skin cancer
  • Inability to provide informed consent
  • Participants who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093612

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Joanne Mortimer Beckman Research Institute
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01093612     History of Changes
Other Study ID Numbers: 09101, NCI-2010-00322, BC095002
Study First Received: March 23, 2010
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by City of Hope Medical Center:
HER2-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014