Malignant neoplasm of breast Cancer
Conditions
Interventions
Current interventions as of 21/08/024:
This prospective, non-randomised, feasibility, cohort study will test the hypothesis that nutrient-metabolism parameters in TNBC and adherence to the WCRF cancer
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 21/08/2024: 1. Patients aged 18 years or older 2. Uni or bilateral TNBC in the breast and/or axilla (including primary, second primary, locoregional recurrence, or inflammatory breast cancer) 3. Clinical recommendation for NACT 4. Ability to provide informed consent 5. Uni- or multi-focal invasive breast cancer of any histological subtype (if multifocal, dominant lesion that is triple negative to be biopsied) and any tumour (T) and clinical node (N) staging. Previous participant inclusion criteria: 1. Patients aged 18 years or older 2. Newly diagnosed uni- or bilateral TNBC in the breast and/or axilla 3. Clinical recommendation for NACT 4. Ability to provide informed consent 5. Uni- or multi-focal invasive breast cancer of any histological subtype (if multifocal, dominant lesion that is triple negative to be biopsied) 6. Tumour staging T1, T2 or T3 7. Clinical node staging cN0 or cN1
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 21/08/2024: 1. Patients diagnosed with pure non-invasive breast cancer (e.g. DCIS) or with non-TNBC invasive subtypes, 2. Patients diagnosed with distant metastatic disease at the time of primary breast cancer diagnosis 3. Inability to provide informed written consent Previous participant exclusion criteria: 1. Patients diagnosed with pure non-invasive breast cancer (e.g. DCIS) or with non-TNBC invasive subtypes (e.g. luminal/HER2 positive) 2. Patients diagnosed with breast cancer locoregional recurrence (i.e. previous history of primary breast cancer) 3. Patients diagnosed with distant metastatic disease at the time of primary breast cancer diagnosis 4. Inability to provide informed written consent 5. Patients with inflammatory breast cancer 6. Tumour staging T4 7. Clinical node staging N2 and N3
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient uptake rate of blood and tumour tissue donation measured using the study Case report form (CRF) at the end of the study 2. Completion rate of the patient surveys measured using study records (CRF) at the end of the study 3. Determine potential variation in the nutritional status of the study participants measured using data from molecular assays and the survey questionnaires at the end of the study 4. Accuracy and compliance of WCRF guideline adherence measured using FFQ and myfood24-based methods of data collection at the end of the study 5. RNA yield from tumour biopsies measured using a spectrometer-based microplate reader at the end of the study 6. Measurement of predictors of chemoresponse by gene expression analysis measured using RNA sequencing or TaqmanTM Low-Density Array at the end of the study | — |
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/08/2024: The patient’s nutritional status will be measured using the following surveys: 1. Validated food frequency questionnaire (FFQ) using EPIC-Norfolk at T0 and T3 2. 24 dietary recall using myfood24.org at T0 and T3 The patient’s nutritional status will also be measured using nutritional profiling of: 3. Blood micro- and macro-nutrient levels (cholesterol and cholesterol precursor/derivatives (oxysterols), vitamins, unsaturated and saturated fatty acids, and eicosanoids) determination using LC-MS/MS and T0 and T3 4. Gene expression in tumour biopsies using RNA sequencing or TaqmanTM Low-Density Array at T0 and T3 5. Anthropomorphic measures (body weight will be measured using a technical balance, height with a stadiometer, and waist and hip circumferences using a tape measure) at T0 6. Tumour size will be measured using Magnetic resonance imaging (MRI) at T0, T1, T2 and T3 7. Physical activity will be measured using the EPAQ2 questionnaire at T0 and T3 T0: Corresponds to the day when patients attend Leeds Teaching Hospitals NHS Trust (LTHT) to have their marker clip placed. For those who already had the marker clip placement done, it is the day they return to LTHT for a second biopsy T1: Corresponds to the end of 2nd neo-adjuvant chemotherapy (NACT) cycle (approximately 8 weeks after T0) T2: Corresponds to the end of 4th or 6th cycle of treatment overall, depending on response seen on the MRI at the T1 timepoint. T3: Corresponds to the day of surgery for tumour resection Previous primary outcome measure: The patient’s nutritional status will be measured using the following surveys: 1. Validated food frequency questionnaire (FFQ) using EPIC-Norfolk at T0 and T3 2. 24 dietary recall using myfood24.org at T0 and T3 The patient’s nutritional status will also be measured using nutritional profiling of: 3. Blood micro- and macro-nutrient levels (cholesterol and cholesterol precursor/derivatives (oxysterols), vitamins, u | — |
Countries
England, United Kingdom
Contacts
Public ContactSue Hartup
Outcome results
None listed