Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorRoyal Marsden NHS Foundation Trust
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (London)
StatusRecruiting
StartedMay 29, 2024
Main results expectedMay 2034
Study endsMay 2034
Registry record updatedApril 16, 2026
Trial IDNCT06681064 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.