Primary breast cancer
Conditions
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Confirmed PD-L1 expression =1% on tumour cells and/or TILs (prescreening phase) -Able to provide written informed consent -Female gender -Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker. -HER2 amplification, IHC 3+ and preferably confirmed by ISH -Tumour and blood samples available. -Age 18 years or older. -Primary breast cancer >20 mm in diameter and/or verified lymph node metastases -Performance status 0-1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: -Distant metastases without chance to cure. -Other malignancies within the last five years. -Patients in child-bearing age without adequate contraception. -Pregnancy or lactation. -History of autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the rate of pCR after optimal neoadjuvant anti-HER2 based systemic therapy, and in a randomised fashion study the added rate of pCR by addition of atezolizumab.;Secondary Objective: To identify therapy predictive factors for the anti-HER2 monoclonal antibodies trastuzumab and pertuzumab plus-minus atezolizumab with a backbone of chemotherapy, using modern molecular biological investigational procedures with analyses by repeated biopsies from an intra-patient longitudinal study design.;Primary end point(s): pCR rate after neoadjuvant treatment as determined on the surgical specimen by a pathologist blinded for the treatment arm.;Timepoint(s) of evaluation of this end point: After neoadjuvant treatment at the moment of surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Objective response rate. -Breast cancer recurrence free survival. -Distant disease-free survival. -Event-free survival. -Overall survival. -Rate of breast conserving surgery. -Morphological, functional and biological characteristics of tumours exposed to cytotoxic and targeted treatment. -Safety. -Patient reported outcome (Quality of life, MSAS) -Treatment-related toxicity.;Timepoint(s) of evaluation of this end point: After surgery (end of treatment 3 months after surgery) and annual follow-up visits during 10 years. | — |
Countries
Sweden
Contacts
Public ContactBreast Centre, Theme Cancer
Karolinska University Hospital
Outcome results
None listed