More than 2 million people are diagnosed with breast cancer every year, and the numbers keep rising1,2.
For the 90% of people diagnosed with early breast cancer, the aim is to find medicines that not only treat the disease but also help them live life on their own terms and reduce the anxiety of it coming back3,4.
We have this great responsibility to design studies that improve patients' chance to avoid the recurrence of their cancer—as well as balance it with their quality of life
Tanya Taran, Vice President and Global Program Head for Oncology at Novartis
For a recent study of a Novartis medicine in breast cancer, that meant standing shoulder to shoulder with patients, their advocates, physician investigators and clinical trial researchers.
Together with Translational Research in Oncology (TRIO)—a global, not-for-profit organization with a unique collaboration model of clinical research professionals, a network of clinical investigators, academic leaders, and patient advocates to optimize clinical trial execution—Novartis developed a study that enrolled more than 5 000 patients across the world.
A research pioneer with expertise in breast cancer, TRIO’s Executive Director Dennis J. Slamon, M.D., had intimate knowledge of the mechanism of action of the Novartis treatment, which had won initial approval in 2017 for treating late-stage breast cancers5. He also shared the belief that Novartis should investigate the potential of this approach in other stages of disease to prevent recurrence.
“With a world-renowned physician scientist who had worked on both the preclinical and clinical studies in the metastatic setting, we knew we had a great partner in Dr. Slamon and TRIO,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. “It truly became a symbiotic collaboration, with these patients firmly at our center.”
Catherine Marle, CEO, TRIO, added: “By collaborating, we have been able to make a difference and reach our common objective to make a positive impact on the lives of patients.”
Taran also had great hopes for the molecule in other stages of disease.
She was fully aware of the ordeal patients experience when undergoing cancer treatment and the profound impact it can have on their daily lives, including the fear and anxiety of their cancer returning3.
With this insight, the trial team and steering committee—which consisted of a range of key opinion leaders and patient representatives—made the decision to reduce the dosing of the drug to optimize safety, improve adherence to the treatment, and ultimately maintain quality of life for patients while still ensuring efficacy.
Treatment approaches developed through careful research are getting so much better at pinpointing which patients need more therapy and which patients can get by with less. We are excited to see trials like this one, where lowering the dosage resulted in side effects that were more manageable and let people get out and live their lives.
Krissa Smith, PhD, Vice President of Mission Partnerships at Susan G. Komen, and patient advocate
Thanks to this and other patient-centric decisions, the trial was a success6.
"These landmark results will change how we treat patients who are in need of new, well-tolerated options that prevent their cancer from coming back," Slamon said at the time.
The mindset that drove the clinical trial is also driving efforts to raise awareness about the disease and the commitment to patient needs.
Currently, teams at Novartis are working with breast cancer patient organizations around the world—listening, engaging, and, importantly, acting to ensure patients get the right medicines and are better equipped to manage their risk of recurrence.
Because for Novartis, a medical breakthrough is only one step toward increasingly better treatments.
“Sadly, tens of thousands of women in the US—and many more around the world—die every year from breast cancer that comes back,” Legos said. “It’s extremely important we bring new therapeutic options forward that offer new hope to patients who are living with uncertainty and anxiety. And we need to do it together.”