PREDIX II HER2 - improving preoperative treatment of HER2 amplified breast cancer

Phase 1

• Conditions: Primary breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004457-24-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 190

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): -Objective response rate.<br>-Breast cancer recurrence free survival.<br>-Distant disease-free survival.<br>-Event-free survival.<br>-Overall survival.<br>-Rate of breast conserving surgery.<br>-Morphological, functional and biological characteristics of tumours exposed to cytotoxic and targeted treatment.<br>-Safety.<br>-Patient reported outcome (Quality of life, MSAS)<br>-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.