We are pleased to inform that the last patient has been enrolled in BARBICAN study.
Last patient, number R146, was randomized at the Arnau de Vilanova Hospital on July 29th 2020, by Dr. Llombart and his team, and has started treatment in the arm of Atezolizumab + Chemotherapy + Ipatasertib.
The BARBICAN study compares the addition of ipatasertib to atezolizumab plus neoadjuvant chemotherapy in patients with triple-negative breast cancer. The primary clinical endpoint is compared pCR rates in the two treatment arms and determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of an immune response over adding atezolizumab alone. In addition, a biological co-primary endpoint would determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of an immune response over adding atezolizumab to chemotherapy in all treated patients.
A total of 146 patients have been randomized amongst the United Kingdom, Germany and Spain. Spain recruited 95 out of the 146, representing 65% of the total trial recruitment, including the first patient enrolled on June 6th, 2019.
Treatment stops and starts were notified to the Spanish Regulatory Agencies at all times. Recruitment was affected by the COVID-19 situation causing the expected end of the trial in April 2020 to be delayed to July 2020. The Sponsor of the trial, Queen Mary, decided to stop the recruitment on March 18th due to concerns on the possible effects of COVID-19 then restarted recruiting on May 3rd, 2020.
None of the patients included in the trial were affected by the virus, which was good, given concerns regarding using immunotherapy treatment in the BARBICAN trial.
We would like to thank all sites, especially during these difficult times. As we re-opened randomisation post COVID we saw higher than expected recruitment rates. The highest recruiters were:
• Dr. Francisco Javier Salvador, Hospital Virgen del Rocio (site 116), with 21 screened patient and 20 inclusions
• Dr. Begoña Bermejo, Hospital Univ. Clínico de Valencia (Site 111), 19 screened patient and 17 inclusions
• Dr. Nieves Ferrer, Hospital Univ. Son Espases (Site121), 14 screened patient and 10 inclusions.
We must once again congratulate the researchers, who despite the health-related setbacks suffered during this year, have actively and effectively recruited all patients.
Results of the study expected in March 2021.
Author: Laura Calabuig