Unknown PHASE2 INTERVENTIONAL 2-arm NCT03144947

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

Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients With Operable or Locally Advanced/Inflammatory HER2-positive Breast Cancer (ImmunHER)

Sponsor: Arithmos srl

Conditions Cancer, Breast

Interventions Docetaxel Pertuzumab Trastuzumab IV Trastuzumab SC

Updated 8 times since 2017 Last updated: Oct 12, 2020 Started: Nov 29, 2016 Primary completion: Mar 15, 2021 Completion: Nov 30, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03144947, this PHASE2 trial focuses on Cancer, Breast and remains ongoing. Sponsored by Arithmos srl, it has been updated 8 times since 2016, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Unknown PHASE2
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE2

Status: Unknown Status → Unknown
Nov 2022 — Jul 2024 [monthly]

Unknown Status PHASE2

Status: Active Not Recruiting → Unknown Status
Jan 2021 — Nov 2022 [monthly]

Active Not Recruiting PHASE2
Nov 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting

▶ Show 3 earlier versions

Mar 2019 — Nov 2020 [monthly]

Recruiting PHASE2
Jun 2018 — Mar 2019 [monthly]

Recruiting PHASE2
Jul 2017 — Jun 2018 [monthly]

Recruiting PHASE2

First recorded

Nov 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Arithmos srl
Clirest s.r.l.
Gruppo Oncologico Italiano di Ricerca Clinica
Mipharm SpA
Temas srl
University Hospital of Parma: Department of Biomedical, Biotechnological and Translational Sciences, Pathological Anatomy and Histology Unit
University Hospital of Parma:Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology
University Hospital of Parma:Statistica medica ed epidemiologia clinica-UO Ricerca e Innovazione

Data source: Gruppo Oncologico Italiano di Ricerca Clinica

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bergamo, Italy , Bologna, Italy , Bolzano, Italy , Brescia, Italy , Candiolo, Italy , Cona, Italy , Cremona, Italy , Genova, Italy , Legnago, Italy , Meldola (FC), Italy and 10 more locations