Roche Breast Cancer Study: Three Quebec Institutions in the Top 3 Worldwide
Thanks to support from each of the FAST TRACK Evaluation Service’s stakeholders, three Quebec hospitals stood out on the international stage for the speed with which they implemented the second phase of Roche’s neoTOV breast cancer study.
The Jewish General Hospital (JGH), with Dr. Stephanie Wong, was the first site activated worldwide.
The McGill University Health Centre (MUHC), with Dr. Jamil Asselah, ranked as the second site activated worldwide and recruited the first patient worldwide.
The Centre hospitalier de l’Université de Montréal (CHUM), with Dr. Rami Younan, was the third site activated worldwide.
These results demonstrate the remarkable mobilization of teams in Quebec, the hospital network’s collaborative strength in clinical research, and Quebec’s leadership in clinical innovation.
“We are extremely proud to witness Quebec’s clinical research excellence shine on the world stage through the neoTOV study. This success is built on the synergy between the FAST TRACK Evaluation Service and our close collaboration with CATALIS and the McPEAK-Sirois Group. By optimizing every stage of research, we are placing patients at the heart of our priorities to provide them with transformative innovations as quickly as possible. CATALIS’ track record in accelerating the entire study start-up process represents the current gold standard in Canada. We are excited to see how other provinces can learn from their experience, to enable Canada to level up our clinical trials at a time of intensifying international competition.” – Dan Edgcumbe, Vice President, Medical and Regulatory Affairs, Roche Canada
Three Quebec Specialists at the Forefront of Breast Cancer Research and Treatment
Through their clinical and research work, Dr. Stephanie Wong, Dr. Jamil Asselah, and Dr. Rami Younan have earned recognition for their expertise in the fight against breast cancer, supported by the cutting-edge research centres in which they practice.
Dr. Stephanie Wong, a surgical oncologist at the JGH, supports people with breast cancer as well as those at high risk of developing the disease. She combines surgical treatment, personalized follow-ups, and adapted prevention, all while also heading a research program focused on the optimization of preventive approaches.
Dr. Jamil Asselah, an associate professor and medical oncologist at the MUHC, is known for his long-standing commitment to clinical research and for implementing practice guidelines to standardize breast cancer treatments within the McGill network.
Dr. Rami Younan, a surgical oncologist at the CHUM, is acclaimed for his approach, which focuses on surgical innovation and patients’ quality of life, and for his commitment to raising public and medical community awareness on preventing this type of cancer.
“It is thanks to McPEAK-Sirois Group’s scientific leadership—allowing us to select the most innovative and impactful studies for breast cancer patients in Quebec—and to the exceptional efficiency of CATALIS in accelerating trial activation, that the MUHC once again asserts itself as a global leader in breast cancer clinical research. By being the first site worldwide to open the neoTOV study and the top-enrolling centre internationally, this collaboration stands as a model of excellence and remains essential to ensuring rapid access to transformative innovations for our patients.”- Dr. Jamil Asselah, medical oncologist at the MUHC and Chair of the McPEAK-Sirois Group’s Scientific Committee.
“We aim to ensure our early-stage, operable breast cancer patients have access to novel and innovative therapies in the neoadjuvant setting, and neoTOV is one example of this for PIK3CA-mutated breast cancer cases. We are proud to have accelerated the opening of this phase II trial so that our Quebec patients can take advantage of this opportunity.” – Dr. Stephanie Wong, surgical oncologist at the JGH
A New Study to Evaluate First-Line Treatment of ER+ Breast Cancer with a PIK3CA Mutation
The neoTOV study, conducted by Roche, aims to evaluate the efficacy and safety of new therapeutic combinations based on inavolisib, a treatment that blocks the proliferation of cancer cells, in people with stage II or III estrogen-receptor positive (ER+) and HER2-receptor negative breast cancer who also have a mutation in the PIK3CA gene.
Nearly three out of four people with breast cancer have some form of ER+¹, in which tumour cells develop under the influence of female hormones, particularly estrogens. Endocrine treatments are designed to block this hormonal action to slow down the growth of tumours. However, nearly one in three people will develop resistance to these treatments, often due to genetic mutations such as PIK3CA¹. This mutation over-activates a biological pathway called PI3K, which stimulates cell division and survival. When it is deregulated, cancer cells can continue to grow despite hormone therapy.
Inavolisib, a selective inhibitor of the PI3K pathway, has been shown in previous studies to be better tolerated and have higher anti-cancer activity compared to existing treatments targeting this pathway. Roche’s neoTOV study aims to evaluate whether this drug, in combination with standard endocrine treatments, can prevent relapses and improve survival rates in people with early-stage breast cancer. This new trial is a promising step towards earlier use of targeted therapies in treating patients with a PIK3CA mutation. It also highlights Quebec’s contribution to the advancement of innovative breast cancer treatments internationally. The Roche study plans to recruit 60 people worldwide, including 6 in Quebec.
To learn more about McPEAK-Sirois, please visit their website.
Are you interested in participating in this clinical trial or in other breast cancer clinical trials? We offer a free Personalized Support Service to help guide you in your search for clinical trials. You can also access Clinical Trials Quebec’s information and services hub. This site contains easy-to-understand educational content, animated infographics, and free tools which will help you to better understand clinical research and what happens during a clinical trial. Information on Roche’s BO45853 clinical study is available through Quebec Health Research’s Public Clinical Trials Database and the www.clinicaltrials.gov website.
The CATALIS Network Aims to Reduce Clinical Trial Authorization Times Through its FAST TRACK Evaluation Service
Thanks to the commitment of healthcare institutions such as the JGH, the MUHC, the CHUM, and pharmaceutical companies such as Roche, CATALIS and its Network of Partners are delighted to stimulate innovation in clinical research and reduce clinical trials’ authorization times by nearly 75%, with the goal of accelerating the development of innovative treatments that improve the lives of patients in Quebec.
CATALIS would like to thank all its public and private partners for their trust, their participation in developing innovative clinical research approval methods, and their commitment to implementing accelerated clinical trials in their institutions.
If you would like more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
¹Schagerholm, C., Robertson, S., Toosi, H., Sifakis, E. G., Hartman, J. (2024). PIK3CA mutations in endocrine-resistant breast cancer. Scientific Reports, 14, Article 12542. https://doi.org/10.1038/s41598-024-62664-1
