Mariana Brandao: Rewarding to see that ALEXANDRA/IMpassion030 trial has been made public to the medical community

Mariana Brandao, Medical Oncologist at Jules Bordet Institute, shared a post on LinkedIn by Michail Ignatiadis, Director of Breast Medical Oncology Clinic and Program at Jules Bordet Institute, adding:

“Almost 8 years ago, I arrived in Brussels to start my Medical Research Fellowship at the Clinical Trial Support Unit of Jules Bordet Institute and the first task that I got in hands was to be a Medical Monitor in the ALEXANDRA/IMpassion030 trial, that was still being developed at that time.

So many years after, it is very rewarding to see that this colossal effort has now been made public to the medical community!

Even if it is a negative trial, there are many clinical and scientific lessons to learn with it, as described below by Michail Ignatiadis.

On a personal side, I’ve learned immensely with this large phase 3 trial: the multiple rounds of discussion that are needed to create such a Protocol, the complicated budget and legal aspects, how to create a trial eCRF, and how to manage all the queries, among so many other things.

Thus, I want to thank all the people that taught me so much throughout those 3 years that I’ve worked on it: my super boss at that time Evandro de Azambuja, the other medical fellows (Noam Pondé, Maria Alice Franzoi, Diogo Martins Branco, Guilherme) and our teacher Sébastien Guillaume, the Project Managers (Christie Freeman and others), the Data Managers (Cristiana de Azevedo v. Stosch), the Informaticians and the overall managers of this project at CTSU (Julie Gaye, Magalie Krieguer).

And of course, also to the people at big against breast cancer (Carmela Caballero, Debora Fumagalli) and at Roche at that time (Catherine Lai).

Thank you all!”

Quoting Michail Ignatiadis’s post about a paper he co-authored with colleagues published in JAMA:

“The final analysis of the ALEXANDRA/IMpassion030 trial is published today in JAMA.

Key Messages:

1. This is a negative study: Adjuvant atezolizumab does not improve invasive disease-free survival and increases treatment-related adverse events when added to standard adjuvant chemotherapy.
2. This is the largest immunotherapy trial in breast cancer and the only adjuvant immunotherapy trial in triple-negative breast cancer (TNBC).
3. The ALEXANDRA/IMpassion030 trial adds to growing evidence across breast cancer and other tumor types that neoadjuvant is more effective way to administer immunotherapy compared to adjuvant.
4. These findings should be considered in multidisciplinary discussions at the time of TNBC diagnosis.
5. Many patients with stage II and III TNBC still undergo upfront surgery. Based on the findings from KEYNOTE-522 and ALEXANDRA/IMpassion030, these patients should be started with neoadjuvant chemoimmunotherapy.
6. For patients with clinical stage I TNBC who undergo surgery and are upstaged postoperatively to pathological stage II or III, adjuvant immunotherapy should not be added to adjuvant chemotherapy.

Acknowledgements:

I would like to thank patients and their families, my coPIs, all study investigators, Roche/Genentech, the Breast International Group (BIG), the Institut Jules Bordet Clinical Trials Support Unit, Frontier Sciences, Alliance Foundation Trials, IEO and China Central Pathology labs and all other academic groups that participated in this study.”

“Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial”

Authors: Michail Ignatiadis, Andrew Bailey, Heather McArthur, Richard Gelber, Martine Piccart et al.

More posts featuring Mariana Brandao and Michail Ignatiadis.