Clinical trial · Observational
Breast Cancer Evolution During Neoadjuvant Systemic Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER+ Breast Cancer | — | UNRESOLVED | — |
| HER2+ Breast Cancer | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of patients recruited undertaking sequential tumour biopsies, blood samples, and MRI.
- timeFrame
- Total 10 year recruitment period
- measure
- Proportion of patients undergoing study procedures within time frames specified by protocol.
- timeFrame
- Total 10 year recruitment period
Secondary outcomes (2)
- measure
- Characterisation of serial molecular and imaging tumour and host profiles and correlation with clinical characteristics, treatment responses and patient outcomes.
- timeFrame
- Total 10 year recruitment period
- measure
- Integration of multiplatform profiling data to develop predictors of response to therapy.
- timeFrame
- Total 10 year recruitment period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSammut 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 34875674