Master Protocol For Metastatic Breast Cancer Needs To Adapt To Rational Combinations

Beyond saving money and creating efficiencies, stakeholders want a master trial to foster true innovation in metastatic breast cancer treatment. Various ways to deal with dosing and other challenges in testing rational combinations of different interventions were discussed at recent workshop.

The master trial approach has become a popular concept in oncology, but as FDA, industry and academia prepare a master protocol for metastatic breast cancer, they are also grappling with the challenge of capturing rational combinations that can help get ahead of resistance and better treat patients.

Stakeholders, which also included patient advocates and leading practitioners, convened in late October to discuss next-generation oncology trials for metastatic...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By 

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Clawbacks And Clinical Trial Set Up Are Among UK’s Investment Deterrents

 

In the wake of MSD’s decision not to invest $1.35bn in the UK, the Association of the British Pharmaceutical Industry has set out the county’s comparative strengths and weaknesses.

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By 

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

More from R&D

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By 

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By 

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

Denmark Tackles GCP Inspection Pain Point: Lack Of Direct Access To Patient Records

 
• By 

Despite being a longstanding requirement under EU and international regulations, the Danish Medicines Agency says its good clinical practice inspectors frequently encounter cases where sponsor-appointed clinical trial monitors are denied direct access to patient records.