Trial Profile
A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin in Patients With HER2+ Early Breast Cancer
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 13 Sep 2023
Price :
$35
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At a glance
- Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin
- Indications Advanced breast cancer; Carcinoma; Early breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms TROIKA
- Sponsors Prestige BioPharma
- 31 Jan 2023 Final results (n=502) comparing efficacy (survival outcomes) and safety of HD201 versus referent trastuzumab in patients with ERBB2-positive breast cancer treated as neoadjuvant therapy, published in the BMC Cancer.
- 21 Apr 2022 Status changed from active, no longer recruiting to completed.
- 11 Mar 2022 Primary endpoint (total pathological complete response rate (tpCR)) has been met, according to a Prestige BioPharma media release.