Trastuzumab SC

DRUG3 trials

Sponsors

Gruppo Oncologico Italiano di Ricerca Clinica, Hoffmann-La Roche, Dana-Farber Cancer Institute

Conditions

Breast CancerCancer, BreastEarly Breast CancerHER2-positive Breast Cancer

Phase 2

Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients

Gruppo Oncologico Italiano di Ricerca ClinicaCancer, Breast

Start: 2016-11-29End: 2021-11-30Target: 65Updated: 2020-10-14

ATEMPT 2.0: Adjuvant T-DM1 vs TH

RecruitingNCT04893109

Dana-Farber Cancer InstituteBreast Cancer, HER2-positive Breast Cancer

Start: 2021-06-16End: 2028-05-01Target: 500Updated: 2026-02-24

Phase 3

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

CompletedNCT03493854

Hoffmann-La RocheEarly Breast Cancer

Start: 2018-06-14End: 2023-06-02Updated: 2024-06-26

Related Papers

114P Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) plus chemotherapy in HER2-positive early breast cancer (EBC): Long-term efficacy and safety analysis of the randomised, open-label, multicentre phase III (neo)adjuvant FeDeriCa study

ESMO Open2024-05-01

Randomized, open-label, phase II, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with locally advanced, inflammatory, or early HER2-positive breast cancer—Immun-HER trial (GOIRC-01-2016)

Journal for ImmunoTherapy of Cancer2023-11-019 citations

Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

npj Breast Cancer2022-11-3010 citations

Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer.

2022-10-074 citations

Population pharmacokinetic and exploratory exposure–response analysis of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer in the FeDeriCa study

Cancer Chemotherapy and Pharmacology2021-06-0914 citations

Abstract PS4-33: Androgen receptors are highly expressed in HER2-positive breast cancers that achieve pCR to anti-HER2 monoclonal antibodies

Cancer Research2021-02-15

Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study.

2020-12-21109 citations

Abstract PD4-07: 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

Cancer Research2020-02-158 citations

Abstract P1-18-19: Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable, locally advanced, or inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Cancer Research2020-02-15

Abstract OT1-03-03: Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Cancer Research2018-02-152 citations