For Black women living with estrogen receptor-positive (ER+) metastatic breast cancer, a new clinical trial offers hope in the quest to overcome treatment resistance and extend survival. The VIKTORIA-1 trial is evaluating a potentially groundbreaking drug called gedatolisib, nicknamed “Get It All,” for its ability to inhibit the PI3K/AKT/mTOR pathway implicated in many cases of endocrine therapy resistance.
What exactly is the VIKTORIA-1 trial?
Dr. Mike Danso, a medical oncologist specializing in breast cancer clinical trials, explains the significance of this study to BDO in a Facebook town hall: “Preliminary data looking at this particular drug using VIKTORIA-1 called gedatolisib…has shown to be very efficacious in patients with or without PIK mutations.” The PI3K/AKT/mTOR pathway, often referred to as the “PAM pathway,” plays a major role in up to 40 percent of ER+ metastatic breast cancers.
The trial aims to incorporate gedatolisib into the standard of care for patients who have progressed on first-line therapies like CDK4/6 inhibitors (Ibrance, Kisqali, Verzenio) combined with an aromatase inhibitor. As Dr. Danso explains, “If you have the PIK3CA mutation, then the standard of care would be the injection, the fulvestrant, plus the alpelisib or another one of these agents to target that pathway.”
However, gedatolisib may offer an improved alternative. “This agent in early breast cancer trials has shown to be very efficacious in patients with or without PIK mutations,” notes Dr. Danso, highlighting its potential benefit regardless of mutation status.
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Why this trial needs Black women
But why is Black representation in this trial so crucial? Patient advocate Ricki Fairley drives the point home: “We need to [be even] more represented than our population. When you start thinking, you know, Black women under 35 get breast cancer at twice the rate of white women, die at three times the rate.”
Sidonie Niba, a senior director at the trial sponsor Celcuity, affirms their commitment to diversity. “As a company, Celcuity, we are very, very focused on making sure that the trial is very representative of the people that suffer the most from breast cancer, especially Black women.”
Despite this intention, Dr. Danso acknowledges barriers: “I think the first challenge is to make sure there’s good representation of African Americans on this trial…we really need 5, 10 percent of the patients on this trial to be [Black] for meaningful subset analysis to be done.”
Achieving representative enrollment is vital, as Dr. Monique Gary, a surgical oncologist, articulates, “It’s so important to see us at the table…When we’re not at the table, we’re on the menu.”
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For Black women impressed with the science but anxious about receiving a placebo, Dr. Danso reassures, “Everybody’s getting at the basic level, the standard of care, which is fulvestrant…Nobody’s getting a placebo or something that’s not effective at all.”
As this innovative trial opens doors, Fairley urges Black women to seize the opportunity: “We have to do this for ourselves…Fight for yourself. Fight like a girl.”
The VIKTORIA-1 trial represents a beacon of hope, a chance for Black women to access a promising new therapy while ensuring the data benefits their community. As Fairley states, “People don’t do clinical trials to advance science. They do clinical trials because they want to see their grandbabies.”
To learn more about clinical trials for Black folks, discover our Clinical Trials Resource Center.
