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
|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|
I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Other Name: 64Cu-DOTA-Trastuzumab
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography
Other Name: PET Scan
Procedure: Therapeutic Conventional Surgery
- 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 ]
- 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 ]
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
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Joanne E. Mortimer 626-256-4673 firstname.lastname@example.org|
|Principal Investigator: Joanne E. Mortimer|
|Principal Investigator:||Joanne Mortimer||City of Hope Medical Center|