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Search / Trial NCT06681064

Breast Cancer Evolution During Neoadjuvant Systemic Therapy

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Nov 7, 2024

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

Neoadjuvant Therapy

ClinConnect Summary

The BELIEVE trial is a research study focused on understanding how breast cancer changes during treatment before surgery. It aims to collect samples of breast cancer tissue and blood from people who are starting treatment, such as chemotherapy or immunotherapy, but have not yet had surgery. By studying these samples, researchers hope to learn why some cancers respond well to treatment while others do not. They also want to find better ways to measure how well the treatment is working and to identify patients who may be at a higher risk of their cancer returning after surgery.

To participate in this study, individuals must be at least 18 years old and have non-metastatic invasive breast cancer that has been confirmed by a doctor. They should be planning to start neoadjuvant therapy, which is treatment given before surgery. However, those with metastatic breast cancer or those who have only received endocrine therapy are not eligible. Participants can expect to provide tissue and blood samples, and in some cases, undergo MRI scans and provide stool samples during their treatment. The study is currently recruiting participants of all genders.

Gender

ALL

Eligibility 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.

About Royal Marsden Nhs Foundation Trust

The Royal Marsden NHS Foundation Trust is a leading cancer treatment and research institution in the UK, renowned for its commitment to advancing oncology through innovative clinical trials and cutting-edge therapies. With a multidisciplinary team of experts, the Trust integrates patient care with groundbreaking research, fostering a collaborative environment to improve outcomes for cancer patients. As a pioneer in the field, the Royal Marsden actively contributes to the development of new treatment protocols and plays a critical role in translating scientific discoveries into clinical practice, ensuring that patients have access to the latest advancements in cancer care.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Stephen-John Sammut

Principal Investigator

Royal Marsden NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported