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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:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02827877

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 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.

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 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.
  • Pertuzumab
  • Trastuzumab

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)
             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
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:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:City of Hope Medical Center

Last Updated

May 18, 2021