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Trastuzumab IV

DRUG5 trials

Sponsors

Gruppo Oncologico Italiano di Ricerca Clinica, Hoffmann-La Roche

Conditions

Cancer, BreastEarly Breast CancerHER2-Positive Early Breast CancerHER2-positive Early Breast CancerInflammatory Breast CancerLocally Advanced Breast Cancer

Phase 2

Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients
NCT03144947
Gruppo Oncologico Italiano di Ricerca ClinicaCancer, Breast
Start: 2016-11-29End: 2021-11-30Target: 65Updated: 2020-10-14
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
CompletedNCT03674112
Hoffmann-La RocheHER2-Positive Early Breast Cancer
Start: 2018-12-19End: 2022-10-12Updated: 2024-01-02

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
A Two-Arm 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 Chinese Participants With HER2-Positive Early Breast Cancer
CompletedNCT04024462
Hoffmann-La RocheHER2-positive Early Breast Cancer
Start: 2020-02-05End: 2026-01-19Updated: 2026-02-20
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
CompletedNCT05415215
Hoffmann-La RocheEarly Breast Cancer, Inflammatory Breast Cancer, Locally Advanced Breast Cancer
Start: 2022-07-05End: 2025-11-07Updated: 2026-02-10

Related Papers

Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study.
2025-05-031 citations
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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
A preferência de profissionais de saúde e pacientes pela via de administração da terapia sistêmica no tratamento do câncer de mama HER2-positivo: uma revisão sistemática da literatura
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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
Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study.
2021-06-1652 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
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Abstract PS4-33: Androgen receptors are highly expressed in HER2-positive breast cancers that achieve pCR to anti-HER2 monoclonal antibodies
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2020-12-21109 citations
Subcutaneous Treatment vs. IV Infusion for HER2-Positive Breast Cancer
Oncology Times2020-05-19
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
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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