Early-stage ER-positive, HER2-negative luminal high-risk breast cancer, HER2-positive breast cancer, triple-negative breast cancer treated with standard of care neoadjuvant therapies. Cancer
Conditions
Interventions
This is a prospective, single-centre, observational translational pilot study in patients with early-stage breast cancer receiving standard-of-care neoadjuvant treatment.
Eligible patients with tripl
additional longitudinal blood samples are collected during follow-up.
Collected samples include FFPE tissue, frozen tumour tissue, fresh tumour tissue, plasma, serum, peripheral blood mononuclear cel
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years or older 2. Histologically confirmed early-stage breast cancer planned for neoadjuvant systemic treatment at Institut Jules Bordet 3. Breast cancer subtype eligible for this observational translational study: 3.1. Triple-negative breast cancer, or 3.2. HER2-positive breast cancer, 3.3. ER-positive/HER2-negative high-risk luminal breast cancer 4. No evidence of metastatic disease at study entry 5. Willing and able to provide written informed consent for collection of tissue, blood, and clinical data 6. Availability of baseline and planned surgical material, with optional on-treatment biopsy where feasible 7. For the TNBC expansion cohort: tumor size at least T1c with node-positive disease, or tumor size at least T2, or otherwise eligible for neoadjuvant pembrolizumab plus chemotherapy according to KEYNOTE-522 and institutional multidisciplinary tumor board decision
Exclusion criteria
Exclusion criteria: 1. Patients not meeting the inclusion criteria 2. Metastatic breast cancer at study entry 3. Refusal or inability to provide informed consent 4. Inability to provide the required research samples according to protocol procedures
Countries
Belgium
Contacts
Public ContactChristos;Marcela Sotiriou;Carausu
;
Outcome results
None listed