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