Clinical trial · Observational
Developing a Diagnostic Tool to Predict Response to Chemotherapy
Developing a Diagnostic Tool, Using SPAG5, for Predicting Clinical Benefit From Standard Anthracycline Combination (AC) in Breast Cancer
- 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)
Every year nearly 62,000 people are diagnosed with breast cancer in the UK. One in eight women in the UK will develop breast cancer in their lifetime. The investigators are developing an inexpensive test to accurately predict how breast cancer patients will respond to the standard chemotherapy Anthracycline (AC). Only 15-20% of patients have no tumour remaining following AC, so a method of treatment selection is urgently needed. Breast cancers are currently treated with a combination of chemotherapy, targeted therapy and surgery. However, breast cancers are not identical; each tumour's individual characteristics affect how they respond to treatment. Recently the investigators discovered a new tumour characteristic, a protein which is unusually active in approximately 20% of breast cancers. It was found that a patient whose tumour showed high activity often respond well to AC, and vice versa. AC is an aggressive treatment which can potentially cause severe side effects, including a risk of permanent heart damage. It is important, therefore, to spare those patients who will not benefit from AC the physical and emotional side-effects of this drug. Currently, there is no predictive test for selecting which patients will benefit from AC and which will not. The investigators have shown that an accurate prediction can be made by testing the activity of a protein called 'SPerm associated AntiGen 5' (SPAG5) in tumour tissue. The aim is to develop a clinical SPAG5 testing kit that can be used by hospital laboratories to determine the activity of SPAG5 in the tumour. This information will help guide the choice of treatment and achieve better patient outcomes. In June 2018 the investigators started a three year National Institute for Health Research (NIHR) funded project to develop a lab test that could form the basis of a SPAG5 testing kit.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPAG5 Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- NUH Adjuvant Breast Cancer Cohort: Historical
- description
- This is a series of breast cancer patients treated with adjuvant therapy, who were identified and samples selected for inclusion in the Nottingham Tenovus Breast research project by Prof Ian Ellis's research group (1986-1999; n=1650). The clinical dataset for this cohort of breast cancer patients has been collected in a master clinical database by the team supporting Professor Ian Ellis. The study research team will work with a pseudo-anonymised copy of this dataset.
- interventionNames
- Diagnostic Test: SPAG5 Assay
- label
- NUH Adjuvant Breast Cancer Cohort: New
- description
- A series of breast cancer patients treated with adjuvant therapy, who were identified and samples selected for inclusion in the Nottingham Tenovus Breast research project by Prof Ian Ellis's research group (2000-2006; n=2000). The clinical dataset for this cohort of breast cancer patients has been collected in a master clinical database by the team supporting Professor Ian Ellis. The study research team will work with a pseudo-anonymised copy of this dataset.
- interventionNames
- Diagnostic Test: SPAG5 Assay
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of primary invasive breast cancer. * Any hormone receptor status (Oestrogen Receptor, Progesterone Receptor). * Any Human epidermal growth factor receptor 2 (HER2) receptor status. * 18 to 90 years old. Exclusion Criteria: * Histological diagnosis of any other cancer type. * Evidence of distant metastatic disease at diagnosis. * Insufficient tumour tissue available for research use in tissue blocks held in the NUH Trust pathology archive. * Outside of stated inclusion age range.
References
Publications (1)
- RESULTAbdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14. PMID 27312051