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Clinical Trial News

CDK4/6 Inhibitors Show Trend Toward Benefit in Early Breast Cancer, Meta-Analysis Finds

  • A meta-analysis of over 12,000 patients with early HR+/HER2- breast cancer showed a trend towards improved invasive disease-free survival with adjuvant CDK4/6 inhibitors.
  • The study did not find a statistically significant improvement in distant relapse-free survival with the addition of CDK4/6 inhibitors to endocrine therapy.
  • Adjuvant CDK4/6 inhibitors were associated with a significantly increased incidence of adverse events, including neutropenia, anemia, and diarrhea.
  • The findings highlight the need for longer follow-up and better patient selection to optimize the use of CDK4/6 inhibitors in early breast cancer.

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

NCT03078751CompletedPhase 2
Novartis Pharmaceuticals
Posted 6/20/2017

Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer

NCT03820830Active, Not RecruitingPhase 3
ETOP IBCSG Partners Foundation
Posted 8/27/2019

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

Savana Leverages AI to Transform EHR Data into Actionable Clinical Insights

  • Savana's AI-powered platform analyzes unstructured electronic health record data across 14 countries in five languages, enabling unprecedented access to real-world clinical evidence.
  • The company's technology has demonstrated significant value during COVID-19 pandemic through the BigCOVIData study, revealing key insights about disease characteristics and predictive factors.
  • Using advanced Natural Language Processing and privacy-preserving techniques, Savana helps pharmaceutical companies and researchers unlock previously inaccessible clinical data while maintaining patient confidentiality.

Libtayo (Cemiplimab) Monotherapy Demonstrates Overall Survival Benefit in Advanced Cervical Cancer

• A Phase 3 trial of Libtayo (cemiplimab) monotherapy in patients with recurrent or metastatic cervical cancer was halted early due to positive overall survival results. • The trial showed a 31% reduction in the risk of death compared to chemotherapy, regardless of PD-L1 status, marking the first immunotherapy to improve survival in this setting. • Libtayo monotherapy led to a median survival of 12.0 months versus 8.5 months with chemotherapy, with regulatory submissions planned for 2021. • The study included women with squamous cell carcinoma or adenocarcinoma, showing survival benefits in both subtypes, with a median age of 51 years.

Advances in Prognostication and Treatment of Polycythemia Vera with Pegylated Interferon and MDM2 Inhibition

Recent studies highlight the efficacy of pegylated interferon (IFN) and MDM2 inhibition in treating Polycythemia Vera (PV), a type of myeloproliferative neoplasm. Pegylated IFN, particularly IFN-α, shows promise in normalizing blood counts, reducing phlebotomy needs, and potentially inducing molecular remissions. Despite its benefits, IFN's side effects limit its use. MDM2 inhibitors, targeting the TP53 pathway, offer a novel approach, with clinical trials demonstrating reduced JAK2V617F allele burdens and improved patient outcomes. These advancements underscore the evolving landscape of PV treatment, emphasizing the need for further research to optimize therapeutic strategies.

Virtual Patient Engagement Reshapes Clinical Trial Design Post-COVID

  • The COVID-19 pandemic has accelerated adoption of virtual patient engagement in clinical trials, particularly benefiting those with mobility challenges and disabilities.
  • Industry experts emphasize the need for early patient involvement in trial design, from initial concept through development, with companies like Janssen implementing structured engagement touchpoints.
  • While digital solutions show promise, researchers must balance virtual approaches with traditional patient care and consider population-specific needs in trial design.

Metastatic Patterns and Treatment Response in Prostate Cancer: New Insights into Disease Progression

  • Prostate cancer exhibits distinct metastatic patterns, with bone (90%) and lung (46%) being the most common sites, while lymph node metastasis indicates poor prognosis and treatment response.
  • Novel imaging techniques like PSMA-PET demonstrate superior sensitivity in detecting metastases compared to conventional methods, enabling earlier intervention and better treatment planning.
  • Circulating tumor cells serve as promising biomarkers for monitoring disease progression and treatment response, with ≥5 CTCs per 7.5ml blood correlating with reduced survival in metastatic patients.

Exercise, Prostate Cancer and Circulating Tumour Cells

NCT02453139CompletedNot Applicable
University of Dublin, Trinity College
Posted 10/1/2014

Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method

NCT02025413CompletedNot Applicable
Duke University
Posted 11/1/2011

Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

NCT02080650CompletedNot Applicable
Duke University
Posted 3/1/2014

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

NCT01193244CompletedPhase 3
Millennium Pharmaceuticals, Inc.
Posted 10/1/2010

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

NCT01957436Active, Not RecruitingPhase 3
UNICANCER
Posted 11/13/2013

Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)

NCT01751438CompletedPhase 2
M.D. Anderson Cancer Center
Posted 3/18/2013

CTC Immune Checkpoint

NCT02456571Completed
Duke University
Posted 11/1/2016

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT00638690CompletedPhase 3
Cougar Biotechnology, Inc.
Posted 5/1/2008

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

NCT03511664CompletedPhase 3
Endocyte
Posted 5/29/2018

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

NCT03721341Active, Not RecruitingPhase 3
David Palma
Posted 2/22/2019

An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

NCT00474383CompletedPhase 2
Cougar Biotechnology, Inc.
Posted 11/1/2006

Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy

NCT01800058Completed
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Posted 1/1/2014

An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

NCT00485303CompletedPhase 2
Cougar Biotechnology, Inc.
Posted 6/1/2007

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

NCT03678025RecruitingPhase 3
SWOG Cancer Research Network
Posted 9/24/2018

Lyme PrEP: Novel Monoclonal Antibody Treatment Enters Human Clinical Trials

  • MassBiologics of UMass Medical School has initiated the first human clinical trial of Lyme PrEP, a pre-exposure prophylaxis using a single monoclonal antibody that could prevent Lyme disease.
  • The trial has enrolled 66 volunteers in Nebraska to evaluate safety and pharmacology, with researchers hoping to determine how long the protective antibody remains in circulation after administration.
  • Unlike traditional vaccines, Lyme PrEP provides immediate protection upon injection and targets Borrelia bacteria in tick guts before transmission, potentially offering a solution to a disease that affects approximately 476,000 Americans annually.

Research Initiative Launches to Address Mental Health Crisis in Rare Disease Diagnoses

  • RBW Consulting partners with Rare Disease Research Partners to investigate the psychological impact of rare disease diagnoses, affecting 3.5-5.9% of the global population.
  • The research project, led by Dr. Tom Kenny, aims to develop comprehensive guidelines for healthcare professionals to better support patients and families during diagnosis.
  • Study findings and industry guidelines are expected to be published by winter 2021, addressing the critical gap in mental health support frameworks for rare disease patients.

Breakthrough Gene Therapy Eliminates Need for Enzyme Replacement in Fabry Disease Patients

  • Canadian researchers have successfully developed a one-time gene therapy treatment for Fabry disease that restored enzyme production to near-normal levels in all five trial participants within one week.
  • The world-first trial, published in Nature Communications, used a lentivirus to deliver functional GLA genes to patients' own blood stem cells, allowing three participants to discontinue biweekly enzyme replacement therapy.
  • Led by Dr. Aneal Khan at Foothills Medical Centre, this pioneering approach represents a potential paradigm shift in Fabry disease management, though long-term monitoring will continue for at least five years.

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