Breast Cancer Evolution During Neoadjuvant Systemic Therapy (BELIEVE)

April 13, 2026 updated by: Royal Marsden NHS Foundation Trust
BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before surgery. In certain cases, MRI scans and stool samples will also be obtained before and during treatment. The samples collected from this study will be used for molecular and genetic research to understand why some cancers respond very well to anticancer treatments, and some do not, develop novel ways of accurately measuring response during treatment, as well as identify which patients are at a higher risk of the cancer coming back after surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Breast cancer is the most common female cancer in the UK and remains one of the leading causes of cancer death. Survival rates have greatly improved over the past forty years due to improvements in early diagnosis, surgical techniques, effective chemotherapy treatments, hormonal therapy, and the introduction of targeted biological treatments. However, despite this, breast cancer continues to be the 4th most common cause of cancer death in the UK and 20% of women diagnosed with this disease do not survive more than ten years after diagnosis.

Systemic anticancer treatments (that is, oral or intravenous treatments such as chemotherapy, targeted therapy and immunotherapy) are routinely given before surgery (called neoadjuvant therapy) in patients with aggressive early and locally advanced breast cancer in order to shrink the cancer and make it more operable. As a result, women receiving neoadjuvant therapy often require less radical surgery to remove their cancer. Clinical trials have shown that the timing of systemic therapy (that is, whether it is given before or after surgery), does not make a difference to survival, and because of this systemic therapy before surgery is now a mainstay of breast cancer treatment.

Clinical trials have also shown that the level of response in both primary breast tumour and nearby lymph nodes to systemic anticancer therapy are strongly associated with cancer relapse and survival. The presence of extensive cancer at the time of surgery is associated with a higher risk of metastatic relapse and a poor prognosis.

This study will deeply analyse samples from a patient's tumour, blood, and stool, as well as data from MRI images, to identify specific features of either the patient or their cancer which could be used to predict whether (a) a treatment is likely to work and (b) once started, whether the treatment is still working. All this data will be combined together to build predictors that can identify: (a) patients who are not responding to therapy and could be directed towards different treatments and (b) patients who are responding very well to treatment and might benefit from therapy de-escalation.

Additionally, by profiling these breast cancers in great detail, this project will allow us to identify new cancer vulnerabilities and drug targets that could then be used for treatment in the future.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Early breast cancer patients suitable for neoadjuvant chemotherapy, targeted therapy, or immunotherapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients recruited undertaking sequential tumour biopsies, blood samples, and MRI.
Time Frame: Total 10 year recruitment period
Total 10 year recruitment period
Proportion of patients undergoing study procedures within time frames specified by protocol.
Time Frame: Total 10 year recruitment period
Total 10 year recruitment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterisation of serial molecular and imaging tumour and host profiles and correlation with clinical characteristics, treatment responses and patient outcomes.
Time Frame: Total 10 year recruitment period
Total 10 year recruitment period
Integration of multiplatform profiling data to develop predictors of response to therapy.
Time Frame: Total 10 year recruitment period
Total 10 year recruitment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Stephen-John Sammut, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2034

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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