NCT05919212: DIAMOND

Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy

Status unknown NA Last updated 15 April 2024

What this trial tests

NA trial testing HER2-D is the use of a non-invasive liquid biopsy method to non-invasively and objectively assess HER2 status at recruitment in Metastatic Breast Cancer in 22 participants. Status unknown.

Timeline

1 February 2023

Primary endpoint
1 June 2024

1 February 2026

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	22
Start date	1 February 2023
Primary completion	1 June 2024
Estimated completion	1 February 2026
Sites	1 location across Italy

Drugs / interventions tested

• HER2-D is the use of a non-invasive liquid biopsy method to non-invasively and objectively assess HER2 status at recruitment

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

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

Sponsor's own description

This is a prospective single-center pilot study phase II non randomized designed to explore the role of liquid biopsy in metastatic HER2-positive breast cancer patients treated with Trastuzumab deruxtecan (T-Dxd) as second line treatment according to international guidelines.

All eligible patients to T-Dxd as second line treatment will receive T-Dxd intravenous at dose of 5,4 mg/kg every three weeks until progression disease or unacceptable toxicities.

Subjects eligible to T-Dxd, who agree to participate in the study, will undergo serial blood samples for liquid biopsy (LB) until progression disease.

The timing of blood drawing will be scheduled as follows:

At each T-DXd administration for the first four cycles of T-Dxd (every three weeks). The next blood drawings will be done every three cycles of T-Dxd (every 9 weeks) until the thirteenth cycle. The next blood drawings will be done every six cycles of T-Dxd (every 18 weeks) until progression disease (documented by medical imaging) For all enrolled patients with available tumour tissue from primary diagnosis or last biopsy from recurrence, tissue samples will be requested for exploratory analysis.

Publications & conference data

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

1. Navigating antibody‒drug conjugates (ADCs): from metastatic to early breast cancer treatment strategies.
   Najdi T, Awad L, Chartouni A, Soueidy C, et al · · 2025 · cited 5× · PMID 40304863 · DOI 10.1007/s10637-025-01525-8
2. Circulating Tumor DNA in Early and Metastatic Breast Cance-Current Role and What Is Coming Next.
   Tegeler CM, Hartkopf AD, Banys-Paluchowski M, Krawczyk N, et al · · 2024 · cited 2× · PMID 39682108 · DOI 10.3390/cancers16233919
3. Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.
   Wu Y, Xue R, Luo X, Liao J, et al · · 2026 · PMID 41777248 · DOI 10.1002/mco2.70638