Advanced Metastatic Breast Cancer
Conditions
Brief summary
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Detailed description
Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion. * Patients must be accessible for follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) | 12 months | evaluate the mutations present in breast cancer of patients with advanced/metastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization) |
Countries
Italy
Contacts
CONTACTNicola Fusco, MD
CONTACTfrancesca lombardi, biologist
PRINCIPAL_INVESTIGATORNicola Fusco, MD
Istituto Europeo di Oncologia
Outcome results
None listed