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Clinical Trial News

The BWEL Trial: A Study on Weight Loss and Breast Cancer Recurrence

The Breast Cancer Weight Loss (BWEL) trial investigates the impact of weight loss on reducing cancer recurrence in overweight or obese women with stage II-III breast cancer. This randomized, controlled trial compares a telephone-based weight loss intervention plus health education materials against health education materials alone, aiming for a ≥10% weight loss through increased physical activity and caloric restriction.

Breast Cancer WEight Loss Study (BWEL Study)

NCT02750826Active, Not RecruitingPhase 3
Alliance for Clinical Trials in Oncology
Posted 9/16/2016

Palbociclib Plus Letrozole Approved for First-Line ER+, HER2- Metastatic Breast Cancer

• Palbociclib, a CDK4/6 inhibitor, received FDA accelerated approval in combination with letrozole for postmenopausal women with ER+, HER2- metastatic breast cancer. • The approval was based on the PALOMA-1 trial, which demonstrated improved progression-free survival compared to letrozole alone in previously untreated patients. • Common adverse events associated with the combination therapy include neutropenia, leukopenia, and fatigue, requiring careful monitoring and dose adjustments. • Clinicians should consider toxicities, quality-of-life issues, and cost when making treatment decisions, as alternative regimens with different toxicity profiles exist.

A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

NCT01227434TerminatedPhase 2
University of California, San Francisco
Posted 9/1/2010

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

NCT01864746CompletedPhase 3
German Breast Group
Posted 10/30/2013

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

PD 0332991 and Cetuximab in Patients With Incurable SCCHN

NCT02101034CompletedPhase 1
Washington University School of Medicine
Posted 6/17/2014

Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

NCT00721409CompletedPhase 2
Pfizer
Posted 9/15/2008

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

NCT00555906CompletedPhase 2
Pfizer
Posted 1/1/2008

FDA Approves Trofinetide for Rett Syndrome Treatment

The US Food and Drug Administration (FDA) has approved trofinetide, a synthetic analog of glycine-proline-glutamate (GPE), for the treatment of Rett syndrome (RTT) in adults and pediatric patients aged 2 years and older. This approval marks a significant milestone in the treatment of RTT, a rare neurodevelopmental disorder, following years of scientific and clinical research.

India Modernizes Clinical Trial Process with Digital System and Mandatory AV Consent Recording

  • India's Central Drugs Standard Control Organisation (CDSCO) launches new IT-enabled system to streamline clinical trial applications, improving transparency and efficiency in trial registration process.
  • Mandatory audiovisual recording of informed consent has been implemented across 90% of Indian trial sites, addressing previous concerns about participant protection and ethical standards.
  • The initiatives aim to bridge the gap between Indian and international clinical trial standards, leveraging India's vast treatment-naïve population of over a billion people across 500+ sites.

Smoking Poses Heightened Health Risks for HIV Patients, Studies Show

  • Recent studies reveal that people living with HIV who smoke lose more years of life from smoking than from HIV itself, with 50-70% of HIV-positive individuals being smokers.
  • Smoking significantly increases HIV patients' risk of opportunistic infections, cardiovascular disease, and medication complications, with up to 60% higher mortality rates observed in smokers.
  • Public health initiatives like Stoptober and e-cigarette adoption are being promoted as harm reduction strategies, with evidence showing e-cigarettes carry only 5% of tobacco's health risks.

FDA Draft Guidance Clarifies Requirements for Confirmatory Trials Under Accelerated Approval

  • The FDA has issued draft guidance on accelerated approval, focusing on when confirmatory trials must be 'underway'.
  • This guidance interprets 'underway' and details factors the FDA will consider before granting accelerated approval.
  • The guidance aims to ensure timely completion of confirmatory trials, as mandated by the Consolidated Appropriations Act of 2023.
  • Stakeholders can submit comments on the draft guidance until March 10, 2025, for consideration by the FDA.

Fulvestrant Shows Overall Survival Benefit Over Anastrozole in First-Line Advanced Breast Cancer

• A phase II trial (FIRST) comparing fulvestrant 500 mg to anastrozole 1 mg in postmenopausal women with ER-positive advanced breast cancer showed a statistically significant improvement in overall survival (OS). • Patients treated with fulvestrant 500 mg had a median OS of 54.1 months compared to 48.4 months with anastrozole, representing a 30% reduction in mortality risk (HR 0.70, P=0.04). • The OS benefit with fulvestrant was generally consistent across pre-specified subgroups, and no new safety concerns were identified during the follow-up period. • These findings suggest fulvestrant 500 mg could be considered as a first-line treatment option for ER-positive advanced breast cancer, especially where access to other therapies is limited.

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

NCT01602380Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/17/2012

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

NICE Provisionally Approves BioMarin's Vimizim for Ultra-Rare Morquio Disease with Real-World Data Requirements

• NICE has issued a provisional approval for BioMarin's Vimizim (elosulfase alfa), priced at £395,000 per patient annually, for treating the ultra-rare Morquio disease affecting 88 patients in England.
• The approval is contingent on implementing real-world data collection and establishing a price cap, marking NICE's innovative approach to managing high-cost rare disease treatments.
• The MPS Society welcomes the decision while expressing concerns about further delays in the approval process, as patients urgently await access to this life-changing therapy.

FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65

Monoclonal AntibodyDrug Approval
  • The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis.
  • Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments.
  • The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.

Ropeginterferon Alfa-2b Shows Promise in Polycythemia Vera Treatment

  • Ropeginterferon alfa-2b demonstrates a high overall response rate of 90% in polycythemia vera (PV) patients, including complete and partial hematologic responses.
  • The study found no dose-limiting toxicities with ropeginterferon alfa-2b, supporting its favorable safety profile and potential for long-term use.
  • Treatment with ropeginterferon alfa-2b led to significant reductions in JAK2 V617F allelic burden, indicating molecular responses in PV patients.
  • The research suggests that ropeginterferon alfa-2b could effectively normalize blood cell counts and prevent thromboembolic complications in PV patients.

Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera

NCT01193699CompletedPhase 1
AOP Orphan Pharmaceuticals AG
Posted 8/1/2010

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