Montreal, November 27, 2023 — The Research Institute of the McGill University Health Centre (RI-MUHC) will host a new Phase 3 randomized clinical trial called TROPION-Breast04, as announced today by the McPeak-Sirois Group, a provincial consortium of cancer centres across Quebec focused on breast cancer research. This trial is intended for patients with triple-negative breast cancer (TNBC) or hormone-receptor (HR)-low/HER2-negative early stage breast cancer who have not yet received treatment.  The trial will evaluate the safety and efficacy of neoadjuvant datopotamab deruxtecan (or Dato-DXd) in combination with durvalumab, followed by adjuvant durvalumab with or without chemotherapy compared to existing standard treatment for TNBC.  We are proud to report that the first patient worldwide to be enrolled in this pivotal trial is a patient of the Cedars Cancer Centre of the McGill University Health Centre (MUHC).

TNBC has a high recurrence rate and a high potential for metastasis.  It shows resistance to conventional treatments, leading to poor prognosis and survival outcomes. TNBC tends to be more common in women under 40 years of age.  There is a need for novel and more effective treatment approaches, hence the excitement for the TROPION-Breast04 clinical trial which has the potential to improve the lives of eligible patients in this setting.

Dr. Jamil AsselahThis study is locally led by Dr. Jamil Asselah, a medical oncologist at the MUHC and an investigator in the Cancer Research Program at the RI-MUHC, as well as chair of the Scientific Committee of the McPeak-Sirois Group.  Dr. Asselah is also a member of the study’s global Steering Committee. 

"Soon, in Quebec, in Canada, and in many other countries, patients diagnosed with triple-negative or HR-low/HER2-negative breast cancer will have an exceptional opportunity to participate in a Phase 3 study exploring innovative drugs. This study offers, in my opinion, a unique chance to improve the chances of recovery, reduce the risk of relapse and enhance quality of life. I strongly encourage all patients considering neoadjuvant chemotherapy to discuss this opportunity with their oncologist,” says Dr. Asselah.

For more information:

Read the press release on website.

Watch a video with Ms. Nancie Brunet, an MUHC patient who received Dato-DXd with durvalumab as adjuvant therapy in a previous study, who shares her treatment experience.

Those interested in participating in the clinical trial can contact [email protected]

Media contact

Fabienne Landry
Communications coordinator, Research
McGill University Health Centre
[email protected]