BARBICAN

OFFICIAL TITLE: A RANDOMISED, OPEN-LABEL PHASE II STUDY TO DETERMINE THE CONTRIBUTION OF IPATASERTIB TO NEOADJUVANT CHEMOTHERAPY PLUS ATEZOLIZUMAB IN WOMEN WITH TRIPLE-NEGATIVE BREAST CANCER.

PROJECT DETAILS

BARBICAN IS AN INTERNATIONAL, RANDOMIZED, NEO-ADJUVANT PHASE II TRIAL IN WOMEN WITH NEWLY DIAGNOSED, NON-METASTATIC, HIGH-RISK, TRIPLE NEGATIVE BREAST CANCER. THE STUDY AIMS TO EVALUATE THE EFFECTS OF ADDING IPATASERTIB TO CHEMOTHERAPY AND ATEZOLIZUMAB IN PATIENTS WITH AND WITHOUT PI3CA/AKT1/PTEN GENETIC ALTERATIONS.

 

THIS IS AN OPEN-LABEL CLINICAL TRIAL WITH TWO DIFFERENT PRIMARY OBJECTIVES. FIRST, THE STUDY AIMS TO EVALUATE THE EFFECTS OF ADDING IPATASERTIB TO CHEMOTHERAPY AND ATEZOLIZUMAB IN PATIENTS WITH AND WITHOUT PI3CA/AKT1/PTEN GENETIC ALTERATIONS. SECOND, TO DETERMINE WHETHER ADDING IPATASERTIB TO ATEZOLIZUMAB AND CHEMOTHERAPY INCREASES THE PROBABILITY OF IMMUNE RESPONSE OVER ADDING ATEZOLIZUMAB TO CHEMOTHERAPY IN ALL TREATED PATIENTS.

IN ADDITION, THIS STUDY WILL ALSO ASSESS THE RELATIONSHIP BETWEEN THE ANTICIPATED ANTI-TUMOUR ACTIVITY OF THE STUDY TREATMENT AND BIOLOGICAL CHARACTERISTICS OF SUBJECTS’ TUMOUR AND BLOOD SAMPLE DERIVATIVES AT BASELINE AND AT THE END OF TREATMENT TO BETTER DEFINE THE OPTIMAL TARGET POPULATION AND TO GAIN INSIGHT IN RESISTANCE MECHANISMS TO THE STUDY TREATMENT.

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

BREAST

II

142

15 In Spain

Spain, UK, Germany

Recruiting

BARBICAN SITES

Hospital Universitari Vall D'Hebron

SPAIN

Institut Català d' Oncologia L'Hospitalet (ICO)

SPAIN

Hospital del Mar

SPAIN

Institut Català d' Oncologia Badalona (ICO)

SPAIN

Hospital Clínic i Provincial de Barcelona

SPAIN

Hospital Universitari Sant Joan de Reus

SPAIN

Institut Català d' Oncologia Girona (ICO)

SPAIN

Hospital Quiron San Camilo- Ruber Juan Bravo

SPAIN

Hospital Clínico San Carlos

SPAIN

Hospital Clínico Universitario de Valencia

SPAIN

Hospital Arnau de Vilanova de Valencia

SPAIN

Hospital Universitario Virgen del Rocío

SPAIN

Hospital Universitario Miguel Servet

SPAIN

Hospital Universitario Virgen de la Victoria

SPAIN

Hospital Universitari Son Espases

SPAIN

Hospital Universitario Ramón y Cajal

SPAIN