The first participants in this large study were recently selected at the Cedars Cancer Centre of the MUHC.
The Research Institute of the McGill University Health Centre (RI-MUHC) is proud to announce the recent initiation of a new randomized Phase 3 clinical trial, TROPION-Breast03, to test the efficacy of datopotamab deruxtecan (or Dato-DXd) with or without durvalumab as an adjuvant therapy for patients with Stage I-III triple-negative breast cancer (TNBC). The first three patients worldwide to be enrolled in this trial are patients of the Cedars Cancer Centre of the McGill University Health Centre (MUHC). The trial is expected to last eight years and enroll more than 1,000 people with TNBC in 19 countries on four continents.
The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo and SWOG Cancer Research Network Clinical Trials Partnerships.
TNBC has a high recurrence rate and a high potential for metastasis. It shows resistance to conventional treatments, leading to very poor prognosis and survival outcomes. TNBC tends to be more common in women under 40 years of age. As such, there is a need for novel and more effective treatment approaches, hence the excitement for the TROPION-Breast03 clinical trial.
“It is an honour to start this trial in Montreal, as it reflects the performance of both the MUHC and the Centre for Innovative Medicine of the RI-MUHC in cancer research and care,” says Dr. Jamil Asselah, a medical oncologist and a researcher in the Cancer Research Program at the RI‑MUHC, who is the principal investigator of the study.
“Starting this kind of study requires extensive logistical resources and highly efficient clinical practices. It is a privilege to be able to offer innovative, investigative treatments to our patients in Montreal. They are very motivated and excited to be among the first in the world to receive them.”
The TROPION-Breast03 clinical trial is designed for patients who have already received neoadjuvant treatment (a treatment that was intended to shrink the tumour pre-operatively) for TNBC, but who still had cancer cells when the tumour was surgically removed. It will evaluate whether Dato-DXd, given alone or in combination with durvalumab, is effective and safe in treating TNBC, as compared to existing treatments.
In TNBC, the cancer cells do not have any of the three targets of the standard breast cancer treatments, namely estrogen receptor (ER), progesterone receptor (PR) and HER2 protein, hence the “triple negative” label. Dato-DXd is designed to target TROP2, a protein that can be expressed on the surface of cancer cells, and selectively deliver a highly potent payload that damages or eradicates the cancer cell. Durvalumab is an immunotherapy, meaning it works with the immune system to find and attack cancer cells. Both Dato-DXd and durvalumab are given by intravenous infusion.
Patients in the trial will be randomly assigned to one of three groups. One group will receive Dato-DXd in combination with durvalumab. Another will receive Dato-DXd as monotherapy. The third group will receive standard therapy (capecitabine chemotherapy with or without pembrolizumab as immunotherapy). The outcomes of all groups will be compared.
“We have great hope that these investigational approaches could decrease the risk of cancer recurrence for patients living with triple-negative breast cancer, the most aggressive breast cancer subtype. We are working hard to be a recognized leader in research so that we can bring the most promising therapies to our cancer patients as quickly as possible,” says Dr. Asselah, who is also an associate professor at McGill University and the chair of the McPeak-Sirois Group’s Executive Scientific Committee, a provincial consortium of cancer centres across Quebec focused on breast cancer research.
“We are proud to host this international study, and for our organization to play a key role in evaluating the efficacy of these potential new treatment approaches for triple-negative breast cancer. Our researchers are leaders in their fields, and we wholeheartedly support their efforts to bring new and promising treatments to patients,” says Dr. Rhian Touyz, executive director and chief scientific officer at the RI-MUHC.
Those interested in participating in the clinical trial can contact clinical.research [at] muhc.mcgill.ca.
TROPION-Breast03 is a global, randomized, open-label, three-arm, multicentre Phase 3 trial evaluating the safety and efficacy of datopotamab deruxtecan with or without durvalumab versus investigator’s choice of therapy (capecitabine and/or pembrolizumab) in patients with Stage I-III TNBC and residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
The primary endpoint of TROPION-Breast03 is invasive disease-free survival (iDFS) as assessed by investigator. The trial plans to randomize 1,075 patients at multiple sites across Asia, Europe and North America.
Daiichi Sankyo and AstraZeneca have a broad clinical development program for datopotamab deruxtecan in TNBC, including TROPION-Breast03. SWOG Cancer Research Network Clinical Trials Partnerships (SWOG CTP) is the lead academic group for the trial and a key collaborator in the trial’s protocol development, U.S. site selection and planned recruitment and analysis.
About the McGill University Health Centre
The McGill University Health Centre (MUHC) is one of the world’s foremost academic health facilities. Building on the tradition of medical leadership of its founding hospitals, the MUHC provides exceptional multidisciplinary patient-centric care in French and in English. Affiliated with the Faculty of Medicine and Health Sciences of McGill University, the MUHC continues to shape the course of adult and pediatric medicine by attracting clinical and research expertise from around the world, assessing the latest in medical technology, and training the next generation of medical professionals. In collaboration with our network partners, we are building a better future for our patients and their families; for our employees, professionals, researchers and students; for our community and above all, for life. www.muhc.ca
About the Research Institute of the McGill University Health Centre
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and healthcare research centre. The institute, which is affiliated with the Faculty of Medicine and Health Sciences of McGill University, is the research arm of the McGill University Health Centre (MUHC)—an academic health centre located in Montreal, Canada, that has a mandate to focus on complex care within its community. The RI-MUHC supports over 450 researchers and around 1,200 research trainees devoted to a broad spectrum of fundamental, clinical and health outcomes research at the Glen and the Montreal General Hospital sites of the MUHC. Its research facilities offer a dynamic multidisciplinary environment that fosters collaboration and leverages discovery aimed at improving the health of individual patients across their lifespan. The RI-MUHC is supported in part by the Fonds de recherche du Québec — Santé (FRQS). rimuhc.ca