Understanding breast cancer response during pre-surgery treatment
Official title: Breast Cancer Evolution During Neoadjuvant Systemic Therapy
Run by Royal Marsden NHS Foundation Trust · NCT06681064 · Data updated 2026-11-12
This study is trying to see how breast cancer responds to treatment before surgery by looking at tissue and blood samples from patients to find out what factors might affect their recovery and risk of cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | May 29, 2024 |
| Main results expected | May 2034 |
| Study ends | May 2034 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06681064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over with histologically confirmed non-metastatic invasive breast cancer who are about to start neoadjuvant chemotherapy, targeted therapy, or immunotherapy.
✕Probably not a fit
Patients with metastatic breast cancer or those receiving neoadjuvant endocrine therapy only may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects breast cancer tissue and blood samples from patients undergoing neoadjuvant systemic therapy before surgery. It aims to investigate the molecular and genetic factors that influence treatment response and identify patients at higher risk of cancer recurrence. Additionally, MRI scans and stool samples may be obtained to enhance the understanding of treatment effects. The findings could lead to improved methods for measuring treatment response and tailoring therapies for better outcomes.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that improve survival rates for breast cancer patients.
How similar studies have gone: Other studies have shown success in understanding treatment responses in breast cancer, making this approach both relevant and promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed non-metastatic invasive breast cancer. 2. Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy. 3. If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy. 4. Be aged 18 years and over. 5. Have given written informed consent to participate. Exclusion Criteria: 1. Metastatic breast cancer at diagnosis. 2. Treatment with neoadjuvant endocrine therapy only. 3. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
Where it's running
-
Royal Marsden NHS Foundation Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Stephen-John Sammut — Royal Marsden NHS Foundation Trust
- Study coordinator: BELIEVE Trial Manager
- Email: BELIEVE@rmh.nhs.uk
- Phone: 02078082887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.