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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

NCT02827877

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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: Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzumab-Based Neoadjuvant Therapy

Clinical Trial IDs

  • ORG STUDY ID: 16079
  • SECONDARY ID: NCI-2016-00570
  • SECONDARY ID: 16079
  • NCT ID: NCT02827877

Conditions

  • HER2 Positive Breast Carcinoma
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer

Interventions

DrugSynonymsArms
Pertuzumab2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Perjeta, rhuMAb2C4, RO4368451Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)
TrastuzumabABP 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-05280014Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Purpose

This pilot clinical 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) 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 3 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 courses in the absence of disease progression
      or unacceptable toxicity. Patients undergo surgery after 6 courses of trastuzumab and
      pertuzumab.

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

Trial Arms

NameTypeDescriptionInterventions
Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)ExperimentalPatients 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 3 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 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 courses of trastuzumab and pertuzumab.

    Eligibility Criteria

            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)
                 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:Percentage of patients with a positive copper Cu 64-DOTA-trastuzumab scan.
    Time Frame:Up to 1 year
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:City of Hope Medical Center

    Last Updated

    February 12, 2018