TROPION-Breast04
Research type
Research Study
Full title
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
IRAS ID
1008502
Contact name
Assim Khan
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat triple-negative breast cancer (TNBC) and HR-low/HER2-negative breast cancer. Breast cancer is the most common type of cancer among women. In people with breast cancer, the body is not able to control the growth of some cells. These extra cells can form tumours in the breast. TNBC is a type of breast cancer where the tumours do not have any hormone receptor (HR) proteins or HER2 proteins. TNBC grows quickly and is especially difficult to treat. HR-low/HER2-negative breast cancer is very similar to TNBC, but the tumours have low levels of HR instead of being negative for HR. If TNBC or HR-low/HER2-negative breast cancer has not spread to other parts of the body, it can often be treated with a combination of surgery and anti-cancer drugs. The standard treatment these patients receive includes pembrolizumab with chemotherapy before surgery and pembrolizumab with or without chemotherapy after surgery (pembrolizumab with chemotherapy treatment plan). But, this combination of drugs doesn’t work well for all patients, and it can lead to medical problems that cause patients to stop treatment. Researchers think that a new treatment plan that includes datopotamab deruxtecan (Dato-DXd) and durvalumab before surgery and durvalumab with or without chemotherapy after surgery (Dato-DXd with durvalumab treatment plan) could be a better treatment option for patients with TNBC or HR-low/HER2-negative breast cancer who are treated with surgery. Dato-DXd is a new drug that is not approved for patients to receive outside of clinical trials and it is designed to find and kill cancer cells. Durvalumab is an approved drug that sticks to the outside of certain tumours to help the immune system to find and destroy the cancer cells.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0136
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion