Clinical trial · Interventional
Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers
NCT02701348CI-TRIAL-00053120BARONETcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast core biopsy | Procedure | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Magnetic Resonance Imaging | Other | — | UNRESOLVED |
| Shearwave elastography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Change in Proliferative response
- timeFrame
- At surgery, min 3 months max 24 months
- description
- Pathological response to treatment by proliferation (Ki67) (%)
- measure
- Change in Pathological response
- timeFrame
- At surgery, min 3 months max 24 months
- description
- Residual cancer burden score
- measure
- Change in Shearwave stiffness
- timeFrame
- 0,3,6, up to 24 months
- description
- shearwave stiffness (kPa)
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women: Defined as \>12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses \<12 months before starting treatment, FSH \>35 IU/L and LH \>40 IU/L. * ER positive (Allred score \>3) invasive breast cancer * Staging as T1-4, N0-2, M0 * Patient agreed to neoadjuvant endocrine therapy as recommended by MDT * Fresh tissue stored at time of diagnostic core biopsy * Suitable for, and tolerant of MRI scan * Fit for surgical intervention at time of entry into study Exclusion Criteria: * Premenopausal or unable to determine menopausal status * Not fit for surgical intervention due to co-morbidities * Contraindication for MRI (including severe claustrophobia) * Current use of HRT, or HRT use at time of diagnostic core biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.