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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | AryoTrust (trastuzumab biosimilar) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients
Published date:
07/28/2022
Excerpt:
Patients were randomly assigned to receive neoadjuvant TA4415V or reference trastuzumab concurrently with docetaxel (TH phase) for 4 cycles after treatment with 4 cycles of doxorubicin and cyclophosphamide (AC phase)….The pCR rates were 37.50% and 34.09% with TA4415V and reference drug, respectively.... Non-inferiority for efficacy was demonstrated between TA4415V and Herceptin based on the ratio of pCR rates in HER2-positive early breast cancer patients.
Secondary therapy:
docetaxel + doxorubicin hydrochloride + cyclophosphamide
DOI:
10.1186/s40360-022-00599-x
Trial ID:
Source:
Title:
AryoTrust® (Trastuzumab) Safety Study
Excerpt:
...- Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens...
Trial ID:
Source:
Title:
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
Excerpt:
...- HER2 positive (Immunohistochemical (IHC) 3+ intensity, amplification of the HER2 gene on fluorescence in situ hybridization (FISH+ ) or HER2 positive results of Chromogenic in situ hybridization (CISH+))....
Trial ID:
