Triple-negative breast cancer (TNBC) accounts for about 10-15% of all breast cancers. It is a cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. The cancer is unlikely to respond to hormonal therapy medicines, or medicines that target the HER2 protein.

A large, multinational pharmaceutical company needed to better understand patient perspectives to optimize protocol and study design and operationalise a study for TNBC. The key objectives were to identify:

• Perceptions about clinical trials and the patient decision-making process
• Barriers and motivating factors related to patient participation
• Tactics to improve patient trial retention
• Potential solutions for increased engagement and improved experience of a diverse patient population
• Strategies for improving the visibility, accessibility and communication surrounding TNBC trials, including strategies that meet the needs of under-served populations

ICON developed and conducted two one-day, in-person Patient Partner Workshops™, with a diverse group of women with TNBC. The workshops were designed with Interactive, hands-on activities to facilitate authentic exchange between the patients and the sponsor. This open dialogue was the key to uncovering actionable insights, which included:

• Patients clearly identified the need for un-blinding following treatment as essential; it is necessary to know what a patient has been treated with as future treatment options are pursued.
• There was a plea for personal and professional support. Patients described their doctor’s office/ treatment center as “clinical and competent”— delivering adequate care but lacking emotional support.
• Patients want education and information to have a voice in their care, rather than just accept the recommendations of their physicians
• Half of the participants expressed that they feel they do not have equal access to clinical trials due to their race or living in a rural location. There was also some evidence of disparities due to socio-economic status and educational level.

The findings from these workshop allowed the sponsor to implement a number of changes, such as:

• The addition of a treatment arm to avoid additional protocol amendments
• Updates to all patient-facing materials to ensure that verbiage, imagery and content are on-target for this group of women.
• New and enhanced site educational outreach, leveraging existing CRA relationships, to address the perceived unconscious biases of sites and HCPs related to the treatment of women with TNBC
• Enhanced disease-state educational efforts, community and advocacypartnerships, study promotional tactics, and strategies to address clinical trial knowledge in the oncology patient community