Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
NCT ID: NCT02827877
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2016-07-15
2026-09-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Copper Cu 64-DOTA-Trastuzumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pertuzumab
Given IV
Positron Emission Tomography
Undergo PET
Therapeutic Conventional Surgery
Undergo surgery
Trastuzumab
Given IV
Interventions
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Copper Cu 64-DOTA-Trastuzumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pertuzumab
Given IV
Positron Emission Tomography
Undergo PET
Therapeutic Conventional Surgery
Undergo surgery
Trastuzumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joanne Mortimer
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FWA 00000692
Identifier Type: REGISTRY
Identifier Source: secondary_id
16079
Identifier Type: -
Identifier Source: org_study_id