Update on the Phase III NATALEE Trial
NBCC and its advocates want to ensure that well-designed clinical trials that may save lives and change the way breast cancer patients are treated move forward quickly with input from advocates. NBCC partners with institutions and organizations on trials that meet our criteria, which include, among other things, the clinical significance of the trial outcomes, the soundness of the methodology, and the trial sponsor and investigators’ willingness to work with advocates.
Since 2019, NBCC has partnered with Translational Research in Oncology (TRIO) and Novartis Pharmaceuticals on NATALEE, a Phase 3, multi-center, randomized, open-label trial to evaluate the efficacy and safety of ribociclib (a CDK 4/6 inhibitor) with endocrine therapy as an adjuvant treatment in patients with HR+/HER2- breast cancer. Ribociclib offers the potential of reducing the risk of recurrence in patients with early, but high-risk breast cancer.
On Monday, March 27, Novartis1 and TRIO2 announced that the NATALEE trial has met its primary endpoint, invasive disease-free survival, at the first interim data analysis. Three years of adjuvant ribociclib plus standard-of-care endocrine therapy (ET) reduced the risk of disease recurrence, compared to standard adjuvant ET alone. While the magnitude of benefit has not yet been detailed, it was announced that the Independent Data Monitoring Committee recommended that the trial be stopped early for evidence of benefit. No updates on critically important secondary endpoints of overall survival or quality of life were given, although the press release did mention that these long-term outcomes will continue to be evaluated. Further data will be presented at an upcoming medical conference.
Ribociclib demonstrated important overall survival benefits in the metastatic setting, and we certainly hope these benefits will also hold true for early breast cancer patients.
Of interest to NBCC advocates, CDK4/6 inhibitors, including ribociclib, are one of many breast cancer treatments that came out of research funded by the Department of Defense Breast Cancer Research Program (DoD BCRP). Funding for the DoD BCRP continues to be an important tool in our mission to end breast cancer.
FDA to Accept Public Comments on Its Draft Guidance for Trial Design Considerations for Accelerated Approval3
The FDA recently released draft guidance titled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics”. The guidance is geared towards sponsors of cancer drugs to provide recommendations for clinical trial design that supports accelerated approval. The FDA is currently seeking input and accepting comments about the draft guidance, which gives NBCC the opportunity to voice our concerns about accelerated approval, surrogate endpoints, and clinical trial design.
NBCC believes the bar is too low for accelerated approval; too many drugs are approved based on surrogate endpoints that fail to translate into clinically meaningful outcomes that matter to people, like living better or living longer.
NBCC is committed to FDA reform that ensures accelerated approvals are based on actual clinical benefit and robust clinical trial designs, not surrogate endpoints or weak single-arm trial designs. We will submit comments to the FDA regarding our position on their draft guidance. Stay tuned.
NBCC Statement on Clinical Trials Diversity
The NBCC Board of Directors approved a Statement on Clinical Trials Diversity. NBCC will use these principles to:
Read the full statement here.
Five Weeks and Counting Until the 2023 Advocate Leadership Summit—Register and Book your Room TODAY!
The Advocate Leadership Summit is almost here! We hope you’re planning to join us on May 6-8, 2023, in Washington, DC. We encourage you to register soon and to book your room at the Park Hyatt. The deadline to receive NBCC’s special room rate is April 14.
This year’s Summit will offer discussion sessions with top researchers and advocates, as well as skill-building, message training, and strategic planning workshops that inform attendees about critical issues and policies. NBCC will host our annual Lobby Day on May 9.
This year, the Summit will include presentations on:
To learn more, you can view the preliminary program here.
For more information about the Summit and how to register, please visit our website.
We hope to see you there!
Deadline Approaching to Apply for the 2023 Project LEAD Institute
The deadline to apply for the 2023 Project LEAD Institute is quickly approaching! NBCC’s premier science training program will be held in La Jolla, CA from July 30 – August 4, 2023. This six-day intensive course provides advocates with a foundation in breast cancer science, as well as an introduction to clinical trial design, epidemiology, and immunology. Attendees will also learn how this scientific knowledge can be put to work in helping NBCC achieve its mission to end breast cancer.
Applications are due no later than April 21, 2023. Applicants are accepted on a monthly rolling basis. Priority will be given to those who have attended an NBCC Advocate Leadership Summit. To learn more about the Project LEAD Institute and how to apply, click here.
The National Breast Cancer Coalition’s mission is to end breast cancer. Every dollar raised is immediately put to work by furthering scientific research, providing collaborative workshops and symposia, and advancing advocacy training and public policy work in Washington, DC, and in state capitals across the country.
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