Perjeta

DRUG6 trials

Sponsors

University of Chicago, MedSIR, BioRay Pharmaceutical Co., Ltd., Biocad, EirGenix, Inc.

Conditions

Breast CancerBreast Cancer Stage IIBreast Cancer Stage IIIEarly Breast CancerSimilarity of Pharmacokinetics and Safety

Phase 1

Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection

CompletedNCT05323981

BioRay Pharmaceutical Co., Ltd.Similarity of Pharmacokinetics and Safety

Start: 2022-04-11End: 2022-10-09Updated: 2023-07-11

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

BiocadBreast Cancer

Start: 2022-08-08End: 2024-01-31Updated: 2023-02-22

Phase 2

Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer

WithdrawnNCT03058939

University of ChicagoBreast Cancer, Breast Cancer Stage II, Breast Cancer Stage III

Start: 2018-11-30End: 2019-06-30Updated: 2019-04-22

Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.

Active, not recruitingNCT03161353

MedSIRBreast Cancer

Start: 2017-06-26End: 2026-11-01Updated: 2025-04-23

Phase 3

Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

Active, not recruitingNCT05802225

BiocadBreast Cancer

Start: 2023-01-30End: 2026-02-20Updated: 2025-07-20

Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.

WithdrawnNCT06884254

EirGenix, Inc.Early Breast Cancer

Start: 2025-05-31End: 2027-12-31Updated: 2025-10-14

Related Papers

Efficacy and safety of the pertuzumab biosimilar BCD-178 versus the originator pertuzumab in patients with HER2-positive locally advanced breast cancer: Results from the international, double-blind, randomized, phase III PREFER trial.

Journal of Clinical Oncology2026-05-27

Comparing <sup>18</sup>F-FDG positron emission tomography (PET) and breast magnetic resonance imaging (MRI) to predict pathological complete response (pCR) and 3-year invasive disease-free survival (3-y iDFS) in patients (pts) with HER2+ early breast cancer (EBC): An unplanned exploratory analysis of PHERGain trial.

Journal of Clinical Oncology2024-05-29

Clinicopathological and molecular predictors of [<sup>18</sup>F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial.

2024-04-085 citations

3-year invasive disease-free survival with chemotherapy de-escalation using an <sup>18</sup>F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial.

2024-04-0344 citations

Abstract 5213: Evaluation of HER2DX risk-score in residual disease (RD) from HER2-positive (HER2+) early breast cancer (EBC) patients (pts) following neoadjuvant trastuzumab and pertuzumab (HP)-based therapy: An exploratory analysis from the PHERGain trial

Cancer Research2024-03-22

Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study.

2022-10-273 citations

Chemotherapy de-escalation using an <sup>18</sup>F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial.

2021-05-18110 citations

Chemotherapy (CT) de-escalation using an FDG-PET/CT (F-PET) and pathological response-adapted strategy in HER2[+] early breast cancer (EBC): PHERGain Trial.

Journal of Clinical Oncology2020-05-2024 citations