Who is sponsoring NCT05735392?

NCT05735392 is sponsored by Consorzio Oncotech.

What condition does NCT05735392 study?

NCT05735392 studies Metastatic Breast Cancer.

Is NCT05735392 still recruiting?

NCT05735392 is currently completed. Last updated 21 February 2023.

Last reviewed 2023-02-21 · How we verify

NCT05735392: GIM21

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Liquid Biopsy: Intercepting Mutational Trajectories of HER2 (Human Epidermal Growth Factor Receptor 2) Breast Cancer (GIM21 Trial)

Completed NA Last updated 21 February 2023

What this trial tests

NA trial testing Both blood and tissues collection for patients with metastatic breast cancer HER2+ pretreated with no more than one line of anti-HER2 therapy for advanced breast cancer. in Metastatic Breast Cancer in 48 participants. Completed in 12 January 2022.

Timeline

7 November 2018

Primary endpoint
12 January 2022

12 January 2022

Quick facts

Lead sponsor	Consorzio Oncotech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	48
Start date	7 November 2018
Primary completion	12 January 2022
Estimated completion	12 January 2022
Sites	9 locations across Italy

Drugs / interventions tested

Both blood and tissues collection for patients with metastatic breast cancer HER2+ pretreated with no more than one line of anti-HER2 therapy for advanced breast cancer.

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Consorzio Oncotech — full company profile →

Who can join

18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open, interventional, non-pharmacological, prospective study. Patients will receive trastuzumab emtansine (T-DM1) at 3.6 mg/kg intravenously every 21 days, as per Summary of Product Characteristics (SmPC). This is a no-profit study.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Monitoring changing patterns in HER2 addiction by liquid biopsy in advanced breast cancer patients.
Giordani E, Allegretti M, Sinibaldi A, Michelotti F, et al · · 2024 · cited 8× · PMID 38951853 · DOI 10.1186/s13046-024-03105-9
Circulating tumor DNA and Response Evaluation Criteria In Solid Tumors: ctDNA-RECIST proof-of-concept in HER2-positive metastatic breast cancer.
Fabi A, Giordani E, Ricciardi E, Arpino G, et al · · 2026 · PMID 41559726 · DOI 10.1186/s13046-025-03605-2
Circulating tumor DNA and Response Evaluation Criteria In Solid Tumors: ctDNA-RECIST proof-of-concept in HER2-positive metastatic breast cancer
Fabi A, Giordani E, Ricciardi E, Arpino G, et al · · 2025 · DOI 10.21203/rs.3.rs-7101376/v1

Verify or expand the search:

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Consorzio Oncotech trials

Trials by the same sponsor.

NCT05817903 — Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients · Phase 2 · recruiting
NCT05754502 — Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients · unknown
NCT05266937 — Atezolizumab Plus CArboplatin Plus Nab-paclitaxel · Phase 2 · unknown
NCT05730647 — Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast C · active not recruiting
NCT04318223 — Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 N · Phase 2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05735392 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Consorzio Oncotech
Last refreshed: 21 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05735392.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing