National Breast Cancer Awareness Month: Redefining Hope in HER-2 Low

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Oct 16, 2024

Breast Cancer Awareness Month has occurred every October for over four decades. The month seeks to promote awareness and education about early detection, treatments, symptoms, and risk factors for breast cancer. Increased overall awareness has helped to improve mortality rates and prognoses, but there’s still work to be done to fight against this disease.

Due to how common the disease has become, new and improved therapies are always being tested for breast cancer. In fact, 1 in 8 women are expected to be diagnosed with some form of breast cancer in their lifetime—that is 1 person nearly every 2 minutes¹. While two of the most common risk factors for getting diagnosed with breast cancer are being born female and getting older, there are many inequities within the indication. For example, in the United States, Black women have a 5% lower risk of developing breast cancer compared to white women but have 38% higher mortality. While there have been many advances in breast cancer, there is still room for advances to be made.

October 13th specifically marks Metastatic Breast Cancer Day. Metastatic breast cancer (MBC) occurs when the cancer has spread to other areas of the body such as bones or organs. Unfortunately, MBC is not considered a curable disease, but it is treatable. Doctors work to treat patients living with MBC by managing pain, providing the best quality of life, and slowing disease spread. While there are people who respond well to available therapies, around 40,000 people still die each year from MBC². It’s becoming increasingly important to discover and develop new therapies that improve the lives and prognoses of people diagnosed with MBC.

A New Avenue in Breast Cancer Therapeutics

HER-2 Low is a relatively new classification of breast cancer and represents at least 55% of breast cancers³. These patients were previously categorized as HER-2 negative, but were shown to respond to HER-2 targeting antibody drug conjugate per the DESTINY-04 study, first released at ASCO 2022. These results offer hope to individuals with advanced breast cancer—particularly those who have exhausted other treatment options.

With this newly classified subgroup comes opportunity for novel therapies, but also comes clinical challenges. HER-2 Low patients—even those in ongoing trials or looking to join a trial—are likely to be more hesitant about entering or remaining in a trial where there is risk that they may be receiving an outdated standard of care treatment, as opposed to receiving a novel, potentially lifesaving therapy. Additionally, for drug developers, there is a need to understand if existing HER-2 targeting therapeutics would be efficacious in this new category of patients, potentially revolutionizing breast cancer treatment and prevention.

In both these scenarios, leveraging an external control arm (ECA) of HER-2 Low patients can supplement or replace an existing control arm to overcome actual or expected attrition, reducing the proportion of HER-2 Low patients assigned to an outdated standard of care therapy.

Presented at the 2023 San Antonio Breast Cancer Symposium, a Medidata-led study aimed to further existing research about potential differences in the biology of metastatic breast cancer in women with HER2 negative disease according to the HER2-low vs.HER2-0 subtype. The team studied anonymized patient-level clinical trial data from the Medidata Enterprise Data Store (MEDS) to compare demographic and clinicopathologic features of patients according to HER2 negative subtype. They also evaluated for differences in patients’ overall survival and progression-free survival according to these subtypes.

Ultimately, researchers found that after analyzing pooled historical clinical trial data of women with metastatic HER-2 negative breast cancer, there were no clinically significant or prognostic differences between HER2-negative subgroups (HER2-low vs HER2-0).

Leveraging the Power of Historical Clinical Trial Data and Patient Voices

Despite the complex and ever-changing landscape of this indication, Medidata is proud to have some of the industry’s most in-depth data for HER-2 Low patients—ultimately which can be leveraged to accelerate clinical and commercial development and bring new therapies to market faster to improve patient outcomes.

Alongside supporting the generation of industry-leading insights using historical patient data, Medidata's Patient Insights Board puts patient advocacy first, ensuring that patient voices are included in the clinical trial process and are reflected in the results

As patient advocate, Anne Marie, put it, “[The Patient Insights Board] supports research being done by helping to develop and design protocols that are answering questions that are meaningful for patients while simultaneously helping to advance science and bring new therapeutics which will benefit the community”.

Where We’re Headed

While the work being done within the breast cancer field is complex and evolving, it’s necessary to continue to understand and educate about the research within this disease. Breast cancer has impacted millions of lives and will only continue to impact more if new therapies are not continuously tested. Medidata is proud to be at the forefront of the research being done to improve prognoses, decrease mortality rates, and ultimately limit the number of lives that this disease affects.