Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy
Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy. DIAMOND STUDY
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Alterations associated with resistent to Trastuzumab Deruxtecan
Time frame: 4 years
Secondary Endpoints
Molecular stratification of patients (dynamic approach by Liquid Biopsy, LB);
Lead Time assessment by Liquid Biopsy.
Association between HER2-2D and outcome in terms of progression.
Eligibility Criteria
Inclusion Criteria: * Must be competent and able to comprehend, sign, and date informed consent prior to any study specific procedures; * Male or female subjects age ≥ 18 years; * Subjects with histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy; * Subjects must have confirmed, per local testing on most recent tumor tissue sample available, an HER2-positive expression, as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines (as defined in the 2013 American Society of Clinical Oncology (ASCO) recommendations for HER2 testing \[7\]) with any ER and/or PgR tumor status; * Subjects must have received no more than one line of treatment including trastuzumab plus or not pertuzumab associated to taxane in the advanced/metastatic setting or …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →