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PHESGO (n=206) | IV PERJETA + trastuzumab (n=203) | |
---|---|---|
Primary endpoint: pertuzumab Cycle 7 Ctrough | 88.7 mcg/mL | 72.4 mcg/mL |
Geometric mean ratio | 1.22 (90% CI: 1.14-1.31) | |
Secondary endpoint: trastuzumab Cycle 7 Ctrough | 58.7 mcg/mL | 44.1 mcg/mL |
Geometric mean ratio | 1.33 (90% CI: 1.24-1.43) |
PHESGO (n=248) | IV PERJETA + trastuzumab (n=252) |
---|---|
59.7% (95% CI: 53.3-65.8) | 59.5% (95% CI: 53.2-65.6) |
*pCR=pathological complete response (ypT0/is, ypN0, defined as the absence of invasive neoplastic cells in the breast and in the axillary lymph nodes).
14% of patients preferred using IV PERJETA + trastuzumab, citing more comfort during administration as the most common reason.*1
*When surveyed after Cycle 6 of adjuvant treatment. Data are based on the primary analysis with a clinical cut-off date (CCOD) of February 24, 2020. As of the CCOD, all 160 patients had completed all 6 cycles of the crossover period.1,5
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PHESGO Prescribing Information. Genentech, Inc. 2020.
PHESGO Prescribing Information. Genentech, Inc. 2020.
Tan AR, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Poster presentation at: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Abstract PD4-07.
Tan AR, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Poster presentation at: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Abstract PD4-07.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
O’Shaughnessy J, Sousa S, Cruz J, et al. Patient (pt) preference for the pertuzumab–trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. https://medically.roche.com/global/en/asset-viewer.eeb4fcc7-b0b5-43d5-9b9a-8f4445f7424f.qr.html?cid=slpsxx2009onbresmo2020. Accessed September 30, 2020.
O’Shaughnessy J, Sousa S, Cruz J, et al. Patient (pt) preference for the pertuzumab–trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. https://medically.roche.com/global/en/asset-viewer.eeb4fcc7-b0b5-43d5-9b9a-8f4445f7424f.qr.html?cid=slpsxx2009onbresmo2020. Accessed September 30, 2020.
ClinicalTrials.gov. A study to evaluate patient preference and satisfaction of subcutaneous administration of the fixed-dose combination of pertuzumab and trastuzumab in participants with HER2-positive early breast cancer (PHranceSCa). https://clinicaltrials.gov/ct2/show/NCT03674112. Accessed May 7, 2020.
ClinicalTrials.gov. A study to evaluate patient preference and satisfaction of subcutaneous administration of the fixed-dose combination of pertuzumab and trastuzumab in participants with HER2-positive early breast cancer (PHranceSCa). https://clinicaltrials.gov/ct2/show/NCT03674112. Accessed May 7, 2020.
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