A5069270463- Cancer Genomics and Diagnostics
- Estrogen and related hormone effects
- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Breast Cancer Treatment Studies
- HER2/EGFR in Cancer Research
- Advanced Breast Cancer Therapies
- Ethics in Clinical Research
- Genetic factors in colorectal cancer
- Economic and Financial Impacts of Cancer
- Cancer Treatment and Pharmacology
- Meta-analysis and systematic reviews
- Pancreatic and Hepatic Oncology Research
- Electronic Health Records Systems
- Cancer Immunotherapy and Biomarkers
- BRCA gene mutations in cancer
- Molecular Biology Techniques and Applications
- Biosimilars and Bioanalytical Methods
- Sarcoma Diagnosis and Treatment
- Cardiac tumors and thrombi
- Cancer-related Molecular Pathways
- Renal cell carcinoma treatment
- Endometrial and Cervical Cancer Treatments
- Single-cell and spatial transcriptomics
- Women's cancer prevention and management
Institute of Cancer Research
2012-2024
Institute of Cancer Research
2006-2022
University College London
2009-2019
University College London Hospitals NHS Foundation Trust
2018-2019
Belfast Health and Social Care Trust
2019
Université du Québec à Montréal
2019
The Christie NHS Foundation Trust
2018
Cambridge University Hospitals NHS Foundation Trust
2018
Beatson West of Scotland Cancer Centre
2018
Royal Marsden NHS Foundation Trust
2018
Tamoxifen, taken for five years, is the standard adjuvant treatment postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse.We conducted double-blind, randomized trial to test whether, after two three years of tamoxifen therapy, switching exemestane was more effective than continuing therapy remainder treatment. The primary end point disease-free survival.Of 4742 enrolled, 2362 were randomly assigned switch...
BackgroundCirculating tumour DNA (ctDNA) testing might provide a current assessment of the genomic profile advanced cancer, without need to repeat biopsy. We aimed assess accuracy ctDNA in breast cancer and ability select patients for mutation-directed therapy.MethodsWe did an open-label, multicohort, phase 2a, platform trial 18 UK hospitals. Participants were women (aged ≥18 years) with histologically confirmed Eastern Cooperative Oncology Group performance status 0–2. Patients had...
PURPOSE CDK4/6 inhibitors are used to treat estrogen receptor (ER)–positive metastatic breast cancer (BC) in combination with endocrine therapy. PALLET is a phase II randomized trial that evaluated the effects of palbociclib plus letrozole as neoadjuvant PATIENTS AND METHODS Postmenopausal women ER-positive primary BC and tumors greater than or equal 2.0 cm were randomly assigned 3:2:2:2 (2.5 mg/d) for 14 weeks (A); 2 weeks, then (B); (C); weeks. Palbociclib 125 mg/d was administered orally...
Post-treatment detection of circulating tumour DNA (ctDNA) in early-stage triple-negative breast cancer (TNBC) patients predicts high risk relapse. c-TRAK TN assessed the utility prospective ctDNA surveillance TNBC and activity pembrolizumab with detected [ctDNA positive (ctDNA+)].c-TRAK TN, a multicentre phase II trial, integrated by digital PCR, enrolled residual disease following neoadjuvant chemotherapy, or stage II/III adjuvant chemotherapy. comprised three-monthly blood sampling to 12...
To compare and describe the quality of life (QOL) women allocated to tamoxifen or exemestane within Intergroup Exemestane Study (IES).Postmenopausal with primary breast cancer who were disease free after 2 3 years randomly assigned switch from continue until 5 treatment completed. A subset IES centers participated in a QOL substudy. The Functional Assessment Cancer Therapy-Breast (FACT-B) endocrine subscale (ES) administered before random assignment at predefined follow-up times. end point...
Alveolar soft-part sarcoma (ASPS) is a rare soft-tissue that unresponsive to chemotherapy. Cediranib, tyrosine-kinase inhibitor, has shown substantial activity in ASPS non-randomised studies. The Cediranib Soft Part Sarcoma (CASPS) study was designed discriminate the effect of cediranib from intrinsically indolent nature ASPS.In this double-blind, placebo-controlled, randomised, phase 2 trial, we recruited participants 12 hospitals UK (n=7), Spain (n=3), and Australia (n=2). Patients were...
LBA527 Background: We have previously shown that switching to exemestane (E) after 2–3 years tamoxifen (T) improves disease free survival (DFS) in postmenopausal (PM) women with early breast cancer (BC). report results 95% of patients (pts) having ≥3 follow-up. Methods: 4724 PM pts (2352 E vs 2372 T) ER +ve/unknown unilateral BC, disease-free T, were randomized continue T or switch complete a total 5 adjuvant endocrine therapy. 122 (56 66 originally reported as unknown later found be −ve. In...
Abstract Background Detection of circulating tumour DNA (ctDNA) in patients (pts) who have completed treatment for early-stage triple negative breast cancer (TNBC) is associated with a very high risk future relapse. Identifiying those at subsequent relapse may allow tailoring further therapy to delay or prevent recurrence. The c-TRAK TN trial assessed the utility prospective ctDNA surveillance pts treated TNBC and activity pembrolizumab (P) detected.. Methods TN, multi-centre phase II...
Purpose The Intergroup Exemestane Study, an investigator-led study of 4,724 postmenopausal patients with early breast cancer (clinical trial information: ISRCTN11883920), has previously demonstrated that a switch from adjuvant endocrine therapy after 2 to 3 years tamoxifen exemestane was associated clinically relevant improvements in efficacy. Here, we report the final efficacy analyses this cohort. Patients and Methods who remained disease free were randomly assigned continue or complete...
Abstract Background Late-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be more efficient than traditional two-arm clinical trial designs but not extensively used. We have gathered the experience of running a number successful together present some operational recommendations. Methods Representatives six UK trials units with in late-phase attended 1-day meeting structured discuss various practical aspects...
11004 Background: ASPS is a rare disease (0.5-1% of soft tissue sarcomas) mainly affecting young people. It unresponsive to conventional chemotherapy. Cediranib (C), an inhibitor vascular endothelial growth factor receptors and other receptor tyrosine kinases, has shown significant activity in single arm phase II trials. CASPS (NCT01337401) was designed permit discrimination between the impact cediranib often intrinsically indolent nature disease. Methods: compared C (30mg od) with placebo...
Abstract Background Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack understanding about which additional resources are required conduct high-quality adaptive trial, compared traditional fixed design. The Costing Trials (CAT) project investigated may be support Methods We conducted mock costing exercise amongst seven Clinical Units (CTUs) UK. Five scenarios were developed, derived...
Abstract Background: Circulating tumour DNA (ctDNA) testing may provide a more current assessment of the genetic profile advanced breast cancer (BC) compared with analysis primary tumour, repeat disease biopsy conducted infrequently in routine clinical practice. The plasmaMATCH trial was designed to assess utility using ctDNA select patients for targeted therapies. Methods: an open-label, multi-centre, multi-cohort platform trial, consisting ~1000 BC, recruited into four parallel treatment...
Challenges EDC does not allow central data cleaning at point of entry or traditional manual CRF tracking upon receipt so alternative approaches are required. specific site training is required and staff need to be encouraged submit immediately following participant visits, instead batching entry. Database user access internet browser compatibility monitoring systems ensure only current have using a supported browser. Conventions for design submission require revision facilitate use sites.
Abstract Introduction Circulating tumour DNA (ctDNA) is found in the plasma of over 90% patients with advanced breast cancer (BC). Screening for presence mutations ctDNA provides a current assessment genetic profile patient's recurrent BC. The plasmaMATCH trial designed to assess potential screening direct targeted therapies cancer. Methods multi-centre phase IIa umbrella platform and therapeutic trial. study will screen 1000 women cancer, who have received prior systemic treatment setting,...
Breast cancer is a diverse and varied disease. Recent research has shown that the collection of multiple biopsies before surgery can help researchers determine how responding to treatment predict for long-term outcomes. However be uncomfortable, sometimes clinicians teams in hospitals may reluctant offer clinical trials requiring several patients who have been recently diagnosed with breast cancer. The Institute Cancer Research Clinical Trials Statistics Unit (ICR-CTSU) oversees large number...
Abstract Adaptive designs are a class of methods for improving efficiency and patient benefit clinical trials. Although their use has increased in recent years, research suggests they not used many situations where have potential to bring benefit. One barrier more widespread is lack understanding about how the choice an adaptive design, rather than traditional affects resources (staff non-staff) required set-up, conduct report trial. The Costing Trials project investigated this issue using...