NCT06681064

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
97mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
May 2024May 2034

Study Start

First participant enrolled

May 29, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2034

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

November 5, 2024

Last Update Submit

April 13, 2026

Conditions

Breast CancerTriple Negative Breast CancerER+ Breast CancerHER2+ Breast Cancer

Keywords

Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients recruited undertaking sequential tumour biopsies, blood samples, and MRI.

    Total 10 year recruitment period

  • Proportion of patients undergoing study procedures within time frames specified by protocol.

    Total 10 year recruitment period

Secondary Outcomes (2)

  • Characterisation of serial molecular and imaging tumour and host profiles and correlation with clinical characteristics, treatment responses and patient outcomes.

    Total 10 year recruitment period

  • Integration of multiplatform profiling data to develop predictors of response to therapy.

    Total 10 year recruitment period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Histologically confirmed non-metastatic invasive breast cancer.
  • Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy.
  • If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy.
  • Be aged 18 years and over.
  • Have given written informed consent to participate.

You may not qualify if:

  • Metastatic breast cancer at diagnosis.
  • Treatment with neoadjuvant endocrine therapy only.
  • Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Related Publications (1)

  • Sammut SJ, Crispin-Ortuzar M, Chin SF, Provenzano E, Bardwell HA, Ma W, Cope W, Dariush A, Dawson SJ, Abraham JE, Dunn J, Hiller L, Thomas J, Cameron DA, Bartlett JMS, Hayward L, Pharoah PD, Markowetz F, Rueda OM, Earl HM, Caldas C. Multi-omic machine learning predictor of breast cancer therapy response. Nature. 2022 Jan;601(7894):623-629. doi: 10.1038/s41586-021-04278-5. Epub 2021 Dec 7.

    PMID: 34875674BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples Blood samples Stool samples

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Stephen-John Sammut

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BELIEVE Trial Manager

CONTACT

02078082887BELIEVE@rmh.nhs.uk

Sophie Cooke

CONTACT

02034373610sophie.cooke@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 8, 2024

Study Start

May 29, 2024

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2034

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

GB(1)