SAFE-DE
Research type
Research Study
Full title
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
IRAS ID
274584
Contact name
Nicholas Turner
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
This is a study for patients with stage 1, the earliest stage with small cancers, HER2 positive and triple negative breast cancer. These are two types of breast cancer that very commonly receive chemotherapy after surgery to try and prevent future breast cancer recurrence. This study aims to establish:
i. The rate at which a new blood test can still detect cancer in the body, despite the cancer in the breast being treated with surgery;
ii. The difference in the rates of future relapse and survival in patients who have have cancer detected in the blood test, compared to those who do not have cancer detected after surgery;
iii. If using the blood tests to detect cancer in the body after surgery can aid clinical decision making.The results of the blood test will be returned to sites for communication to patients. It is known that patients with cancer detected in the blood test after surgery have a substantially worse prognosis than patients with stage 1 cancers as a whole. This information may be useful to the patient’s oncologist in selecting the most appropriate chemotherapy treatment.
Patients with stage 1 HER2 positive and triple negative breast cancer in routine clinical practice, if advised to have chemotherapy, are usually advised to receive short, lower dose chemotherapy regimens. Patients with blood tests that detect cancer may be benefit from having full dose chemotherapy regimens to give the best chance of cure. All treatment decisions will be made as part of the patients’ standard care.
If patients choose not to have chemotherapy as part of their standard of care, additional blood tests will be sent at 6 weeks and 3 months after surgery, to give the best chance of the blood test detecting residual cancer in the body, which would indicate the need for chemotherapy.
Patients will also have other blood tests taken for research purposes. Patients will have a blood sample taken before surgery, and at 6 and 12 months after surgrey. We don’t fully understand how to interpret the results of these test, we would like to learn about this in the study, and the results of these blood test will not be returned to sites or patients.
Tissue and plasma samples collected in the study protocol will also be stored for future analysis.
A parallel study will also be run by Massachusetts General Hospital in the USA.
The blood test checks for the presence of circulating tumour DNA (or ctDNA for short). The blood test detects cancer DNA in the blood plasma, as a sign that cancer is somewhere in the body. In this form we will often refer to ctDNA detection or a ctDNA blood test.REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0312
Date of REC Opinion
1 Dec 2021
REC opinion
Further Information Favourable Opinion