Actively Recruiting
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2023-06-22
400
Participants Needed
2
Research Sites
287 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to assess the rates of circulating tumour DNA (ctDNA) in patients treated with surgery for stage 1 breast cancer that is HER2 positive or triple negative. The study will involve collecting blood samples from patients before and after surgery, if patients are enrolled after surgery, blood samples will be collected after the procedure. On the follow-up visit, the results obtained from the blood tests will serve as a diagnostic method to discern adverse outcomes in the groups of patients with positive and negative ctDNA detection. Also, the results obtained will aid physicians in determining treatment courses for patients, in order to reduce the intensity of adjuvant chemotherapy. By identifying the patients with residual disease with ctDNA analysis, it is possible that this will improve disease prognosis.
CONDITIONS
Official Title
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed breast cancer that is HER2 positive by 2018 ASCO-CAP guidelines or triple negative defined by specific ER, PR, and HER2 testing
- Stage 1 cancer excluding pT1aN0; primary tumor size 6-20mm with normal or biopsy-negative axilla before surgery, or specific pathological staging after surgery including pT1b or pT1c with pN0 or pN1mi, or pT1a with pN1mi
- Consent given before surgery (preferred) or within 2 weeks after surgery; consent after surgery may be extended to 4 weeks
- Planned and fit to receive full standard post-operative chemotherapy, including HER2 targeted therapy if appropriate
- Ability to provide informed consent and comply with study procedures including blood tests and five-year follow-up
You will not qualify if you...
- Presence of distant metastatic disease
- Multifocal invasive cancer
- Diagnosis of another cancer within the last 5 years except resected non-melanoma skin cancer or cervical intraepithelial neoplasia
- Any prior treatment for current breast cancer except surgical resection if enrolling after surgery
- Known infection with HIV, hepatitis B, or hepatitis C
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Trial Site Locations
Total: 2 locations
1
The Royal Marsden NHS Foundation Trust, Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
2
The Royal Marsden NHS Foundation Trust, Sutton
Sutton, United Kingdom, SM5 5PT
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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