Understanding breast cancer response during pre-surgery treatment
Breast Cancer Evolution During Neoadjuvant Systemic Therapy
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT06681064 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with metastatic breast cancer or those receiving neoadjuvant endocrine therapy only may not benefit from this study.
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 performed: Other studies have shown success in understanding treatment responses in breast cancer, making this approach both relevant and promising.
Eligibility criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.