Phase III, randomized, open-label trial designed to demonstrate non-inferiority of PHESGO compared to IV PERJETA and trastuzumab.
Treatment cycles with PHESGO or IV PERJETA + trastuzumab were received every 3 weeks. Patients received adjuvant radiotherapy and endocrine therapy as per investigator’s discretion.
Primary endpoint: Non-inferiority of the Cycle 7 (i.e., pre-dose Cycle 8) pertuzumab serum Ctrough.
Secondary endpoints: Non-inferiority of the Cycle 7 (i.e., pre-dose Cycle 8) trastuzumab Ctrough, efficacy (pCR),‡ and safety.
Stratification factors: Hormone receptor status; clinical stage at presentation (Stage II-IIIA or IIIB-IIIC); type of chemotherapy.
*PHESGO dosing: 1200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase loading dose, followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase maintenance dose.
†IV PERJETA dosing: 840 mg loading dose, 420 mg for subsequent cycles; IV trastuzumab dosing: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles. In adjuvant period, substitution of IV trastuzumab for subcutaneous trastuzumab (trastuzumab-oysk) was permitted at investigator discretion. Trastuzumab-oysk was given as a fixed dose of 600 mg. 61 patients received trastuzumab-oysk.
‡pCR=pathological complete response (ypT0/is, ypN0, defined as the absence of invasive neoplastic cells in the breast and in the axillary lymph nodes).
Chemotherapy regimens: ddAC dosing: doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) every 2 weeks; AC dosing: doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks; paclitaxel dosing: 80 mg/m2 weekly; docetaxel dosing: 75 mg/m2 every 3 weeks. Docetaxel dose could be escalated to 100 mg/m2 at subsequent cycles at investigator’s discretion.
AC=doxorubicin + cyclophosphamide; ddAC=dose-dense doxorubicin-cyclophosphamide; ER=estrogen receptor; PgR=progesterone receptor.
Phase II, randomized, open-label, crossover trial of patients with HER2+ early breast cancer. The primary objective of the study was to evaluate patient preference for PHESGO.
Primary endpoint: Percentage of patients who preferred PHESGO over IV PERJETA + trastuzumab when surveyed after Cycle 6 of adjuvant treatment.
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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