Triple-negative breast cancer: A new clinical study opens new and promising therapeutic prospects

Montreal, November 27, 2023 – The McPeak-Sirois Group, a breast cancer clinical research consortium is pleased to announce the launch of a new global, randomized Phase 3 clinical trial,  TROPION-Breast04.  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) that enrolled another 2 since then.

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.

The study aims to enroll approximately 1,700 patients with TNBC or HR-low/HER2-negative breast cancer in 19 countries across five continents.  The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo.

This study is locally led by Dr. Jamil Asselah, a medical oncologist at the MUHC, an investigator in the Cancer Research Program at the Research Institute of the 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.  Dr. Asselah states: “In Quebec, in Canada, and in many other countries, patients diagnosed with triple-negative or HR-low/HER2-newgative breast cancer 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».

In TNBC, cancer cells do not have any of the three usual targets for breast cancer treatments, namely estrogen receptor (ER), progesterone receptor (PR) and HER2 protein, hence the “triple negative” label.  Dato-DXd is an antibody drug conjugate (ADC) designed to target TROP2, a protein that can be expressed on the surface of cancer cells, and to selectively deliver a highly potent payload that damages or eradicates the cancer cells. 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 two groups. The first group will receive neoadjuvant (preoperative treatment that aims to reduce the size of the tumour) Dato-DXd in combination with durvalumab, followed by adjuvant treatment with durvalumab with or without chemotherapy. The second group will receive neoadjuvant pembrolizumab with chemotherapy, followed by adjuvant treatment with pembrolizumab with or without chemotherapy. The results of each group will be compared.

Those interested in participating in the clinical trial can discuss it with their physician.

Quotes:

Dr. Dominique Johnson, Executive Director of the McPeak-Sirois Group, says: “We are proud to participate in this important international study and that six of the seven Quebec hospitals participating in this study are members of our organization.  This significant participation by our Group makes it possible to offer access to these innovative and promising treatments to patients from several regions of Quebec.”  Participating hospitals from our Group include McGill University Health Centre, Jewish General Hospital, Centre hospitalier de l’Université de Montréal, Hôpital Maisonneuve-Rosemont, Centre hospitalier universitaire de Sherbrooke and Hôtel-Dieu de Lévis.

Kimberly Carson, CEO of Breast Cancer Canada, is inspired by the contributions from 17 hospitals across the country, along with the opportunity for Canadian patients to take part: “With more research, we know we can end breast cancer. We urge breast cancer patients who are eligible to consider participating in this pivotal Canadian study. Together we can make progress and change breast cancer outcomes.

For Cédric Baudinet, Director, Investments and health promotion at the Quebec Breast Cancer Foundation: “The launch of the TROPION-Breast04 trial is a fantastic opportunity for people affected by TNBC to benefit from an additional therapeutic option, in a context where they are limited for this type of cancer. It is of course a note of hope for people affected by breast cancer but also great news for access to the best therapies in Quebec thanks to clinical research”.

About TROPION-Breast04

TROPION-Breast04 is a global, randomised, open-label, double-arm, Phase 3 trial evaluating the efficacy and safety of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in patients with previously untreated Stage II-III TNBC or HR-low/HER2-negative breast cancer.

The primary endpoints of TROPION-Breast04 are pathological complete response and event-free survival. A key secondary endpoint is overall survival (OS) and additional secondary endpoints include distant disease-free survival, participant-reported outcomes, pharmacokinetics, immunogenicity, and safety and tolerability.

Daiichi Sankyo and AstraZeneca are leading an extensive clinical development program for datopotamab deruxtecan for the treatment of TNBC, including TROPION-Breast04.

About the McPeak-Sirois Group

The McPeak-Sirois Group is a charitable organization whose mission is to fight breast cancer more effectively by increasing patients’ access and participation to clinical trials. The Group’s scientific committee is made up of internationally renowned scientists who oversee the selection of clinical studies offered to the consortium’s member hospitals. Co-founded in 2015 by Susan McPeak, a breast cancer survivor, and Charles Sirois, a well-known entrepreneur, the McPeak-Sirois Group is committed to promoting research that cares by bringing it closer to breast cancer patients throughout Quebec.

About Breast Cancer Canada

Breast Cancer Canada (formerly the Breast Cancer Society of Canada) is a national charity dedicated to saving lives through breast cancer research. With a focus on precision oncology (personalized care), it is the only national breast cancer organization in Canada that has a clear mandate to raise money for research. The organization receives no government funding, meaning all research is funded through the generosity of donors.

About the Quebec Breast Cancer Foundation

For more than 29 years, the Quebec Breast Cancer Foundation has been putting people with breast cancer and their loved ones at the heart of its mission through research and innovation, support and awareness. The QBCF has raised more than $64 million in Quebec, which has been distributed in Quebec for cutting-edge research and to defend the interests of people with breast cancer and their loved ones. Families, researchers, volunteers, and donors all share the same hope: a future without breast cancer.