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Trial record 13 of 18 for:    cu-64

Copper (Cu) 64-DOTA-Trastuzumab PET Imaging in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Patients With HER2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02827877
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE April 26, 2016
First Posted Date  ICMJE July 11, 2016
Last Update Posted Date June 6, 2019
Study Start Date  ICMJE July 15, 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • Percentage of patients with a positive copper Cu 64-DOTA-trastuzumab scan. [ Time Frame: Up to 1 year ]
  • Pathologic response to neoadjuvant chemotherapy which is determined at the time of definitive surgery (lumpectomy or mastectomy). [ Time Frame: Up to 1 year ]
  • Additional exploratory markers include the SERPINA and proteomic assessments. [ Time Frame: Up to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02827877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2016)
  • SERPINA1 expression. [ Time Frame: Baseline ]
  • SUV measurement by 64Cu-DOTA trastuzumab PET [ Time Frame: Baseline ]
  • SUV measurement by FDG-PET and 64Cu-DOTA trastuzumab PET in patients with a pCR compared to patients without a pCR. [ Time Frame: Up to 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Copper (Cu) 64-DOTA-Trastuzumab PET Imaging in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Patients With HER2 Positive Breast Cancer
Official Title  ICMJE Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzumab-Based Neoadjuvant Therapy
Brief Summary This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a patient's response to trastuzumab and pertuzumab before surgery in patients with locally advanced HER2 positive breast cancer.
Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1 antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the HER2+/ER+ patients and in all patients.

II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete pathologic response (pCR) versus (vs) non-pCR patients.

OUTLINE:

Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and 2. Within 4 days after completion of PET scans, patients then receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2 Positive Breast Carcinoma
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
Intervention  ICMJE
  • Radiation: Copper Cu 64-DOTA-Trastuzumab
    Given IV
    Other Name: 64Cu-DOTA-Trastuzumab
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Pertuzumab
    Given IV
    Other Names:
    • 2C4
    • 2C4 Antibody
    • MoAb 2C4
    • Monoclonal Antibody 2C4
    • Perjeta
    • rhuMAb2C4
    • RO4368451
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other Name: PET Scan
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
  • Biological: Trastuzumab
    Given IV
    Other Names:
    • ABP 980
    • Anti-c-ERB-2
    • Anti-c-erbB2 Monoclonal Antibody
    • Anti-ERB-2
    • Anti-erbB-2
    • Anti-erbB2 Monoclonal Antibody
    • Anti-HER2/c-erbB2 Monoclonal Antibody
    • Anti-p185-HER2
    • c-erb-2 Monoclonal Antibody
    • HER2 Monoclonal Antibody
    • Herceptin
    • Herceptin Biosimilar PF-05280014
    • Herceptin Trastuzumab Biosimilar PF-05280014
    • MoAb HER2
    • Monoclonal Antibody c-erb-2
    • Monoclonal Antibody HER2
    • PF-05280014
    • rhuMAb HER2
    • RO0452317
    • Trastuzumab Biosimilar ABP 980
    • Trastuzumab Biosimilar PF-05280014
Study Arms  ICMJE Experimental: Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)
Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.
Interventions:
  • Radiation: Copper Cu 64-DOTA-Trastuzumab
  • Other: Laboratory Biomarker Analysis
  • Biological: Pertuzumab
  • Procedure: Positron Emission Tomography
  • Procedure: Therapeutic Conventional Surgery
  • Biological: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be women who have histological confirmation of HER2 positive breast cancer
  • The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI)
  • The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
  • Patients may not have received prior HER2 directed therapies
  • Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)
  • Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
  • Ability to provide informed consent
  • Negative Serum Pregnancy test

Exclusion Criteria:

  • Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
  • Concurrent malignancy other than non-melanoma skin cancer
  • Patients must not have known metastatic disease
  • Patients must not have received prior treatment for the current breast cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02827877
Other Study ID Numbers  ICMJE 16079
NCI-2016-00570 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16079 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Joanne Mortimer City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP