Quantum Leap Healthcare Collaborative

News Update

Widely hailed as the future of phase II drug development, the adaptive I-SPY2 platform trial has set a new benchmark for efficiency, through innovation in trial design and clinical operations.

Upcoming FDA workshop: "Clinical Trials to Optimize Outcomes in Early Breast Cancer"

Multiple I-SPY investigators scheduled to present

The FDA Oncology Center of Excellence, in collaboration with theUCSF-Stanford Centers of Excellence in Regulatory Science and Innovation (CERSI) will hold a public workshop to explore clinical trial designs and innovations that will aid in ioptimizing outcomes in early breast cancer.

The workshop is scheduled for October 29, 2018 at the FDA White Oak Campus in Silver Spring, MD.

The objectives of the workshop are to: 

  • Provide a forum for open discussion between all stakeholders on strategies to optimize outcomes in early breast cancer
  • Discuss trials of de-escalation and targeted escalation of systemic therapy in early breast cancer
  • Discuss assessment of response in neoadjuvant trials in early breast cancer with a focus on endpoints that may support regulatory approval
  • Discuss feasibility challenges of conducting modern early breast cancer clinical trials and the need for robust evidence generation to satisfy regulatory/payer requirements

The workshop will also be live streamed for those unable to attend in person.

More information and registration details

Media Contact:

Karyn DiGiorgio
Quantum Leap Healthcare Collaborative