A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy as Neoadjuvant Therapy in Patients With HER2-Positive Early Breast Cancer

Update Il y a 4 ans
Reference: EUCTR2014-000156-28

Woman and Man

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Extract

The primary objective of this study is to evaluate the cardiac safety of neoadjuvant treatment with the following regimens: • ddAC-->T+ PH: Dose-dense doxorubicin and cyclophosphamide (ddAC) given every 2 weeks for four cycles with granulocyte colony-stimulating factor (G-CSF) support as needed according to local guidelines, followed by weekly paclitaxel (T) for 12 weeks, with pertuzumab and trastuzumab (PH) given every 3 weeks from the start of paclitaxel (Cohort A). • FEC-->D+ PH: 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) given every 3 weeks for four cycles, followed by docetaxel (D) given every 3 weeks for four cycles, with pertuzumab and trastuzumab (PH) given every 3 weeks from the start of docetaxel (Cohort B).


Inclusion criteria

  • HER2-POSITIVE, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER