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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

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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

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.

Condition or disease Intervention/treatment Phase
HER2 Positive Breast Carcinoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Radiation: Copper Cu 64-DOTA-Trastuzumab Other: Laboratory Biomarker Analysis Biological: Pertuzumab Procedure: Positron Emission Tomography Procedure: Therapeutic Conventional Surgery Biological: Trastuzumab Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzumab-Based Neoadjuvant Therapy
Study Start Date : July 15, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Percentage of patients with a positive copper Cu 64-DOTA-trastuzumab scan. [ Time Frame: Up to 1 year ]
  2. Pathologic response to neoadjuvant chemotherapy which is determined at the time of definitive surgery (lumpectomy or mastectomy). [ Time Frame: Up to 1 year ]
  3. Additional exploratory markers include the SERPINA and proteomic assessments. [ Time Frame: Up to 1 year ]

Other Outcome Measures:
  1. SERPINA1 expression. [ Time Frame: Baseline ]
  2. SUV measurement by 64Cu-DOTA trastuzumab PET [ Time Frame: Baseline ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02827877


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Joanne E. Mortimer    626-256-4673    jmortimer@coh.org   
Principal Investigator: Joanne E. Mortimer         
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: NCT02827877     History of Changes
Other Study ID Numbers: 16079
NCI-2016-00570 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16079 ( Other Identifier: City of Hope Medical Center )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Copper
Trastuzumab
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances