Rethinking Breast Cancer Trials: A Clinical Perspective from Dr. Sud Agarwal, CEO of iNGENū CRO

At 38, Rachel had weathered a double mastectomy, chemotherapy, and years of hormone therapy. Her scans were clear. Her doctors were pleased. But Rachel still struggled with lingering fatigue, joint pain, and a sense that her treatment story was being measured by numbers that didn't fully reflect her reality.

Her experience isn't uncommon. For many breast cancer patients, surviving the disease is only one part of the journey. The other part, living fully after treatment, is often overlooked in clinical trials. According to Dr. Sud Agarwal, CEO of iNGENū CRO, that gap in focus is long overdue for change.

Redefining Success in Breast Cancer Trials

For decades, breast cancer research has relied heavily on metrics like overall survival (OS) and progression-free survival (PFS) to evaluate treatment success. These measures remain essential. But as treatments become more effective and long-term survival improves, they're no longer enough on their own.

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"Living longer is important," says Dr. Agarwal. "But what's equally important is how patients are living."

That's why iNGENū CRO, based in Australia, is pushing for trial designs that go beyond tumor response. Their studies consider broader outcomes—such as quality of life, functional ability, and emotional wellbeing that can better reflect how treatments impact a patient's daily life.

A Complex Disease Needs Nuanced Research

Breast cancer is not one condition but many. It includes hormone receptor-positive, HER2-positive, and triple-negative subtypes, each with distinct behaviors and treatment responses. Modern diagnostic codes, like those in ICD-11, now capture this diversity.

But recognizing these subtypes isn't enough, Dr. Agarwal says. Trials must also be designed with this complexity in mind. Without careful stratification, data from patients with vastly different disease profiles can blur important results.

"We can't afford one-size-fits-all research," he notes. "Precision medicine starts with precision in trial design."

Closing the Gaps in Clinical Trial Design

Despite years of progress, many trials still leave blind spots unaddressed. Underrepresentation of women from diverse racial and ethnic backgrounds is a persistent issue. Inconsistent biomarker validation and poor adherence tracking also compromise the accuracy of results.

Dr. Agarwal points out that high dropout rates are especially common in long-term breast cancer trials. "If we're not supporting patients through the full course of treatment, we're not getting the full picture of how effective it really is," he says.

To help fix this, iNGENū CRO incorporates digital tools that track patient adherence and uses centralized imaging standards to ensure data consistency.

Learning from Setbacks

Not all research ends in success. Drugs like iniparib and bazedoxifene fell short of expectations during clinical trials. But those so-called failures have value.

Failed studies often shed light on why a treatment didn't work—whether it was a dosing issue, an overly broad patient population, or a poorly chosen endpoint. These lessons, Dr. Agarwal says, are vital for refining future protocols.

"Every study tells us something," he says. "Even when outcomes fall short, the insights are what push the field forward."

Smarter Endpoints for a Smarter Future

iNGENū's research incorporates a wide range of measures beyond traditional survival rates. These include disease-free survival (DFS), time to progression (TTP), duration of response (DoR), and patient-reported outcomes.

In neoadjuvant studies, for example, early indicators like pathological complete response (pCR) can help determine whether a treatment is worth pursuing further. These kinds of surrogate endpoints have already played a role in expediting access to HER2-targeted therapies.

Dr. Agarwal emphasizes the importance of these newer measures. "We need to evaluate not just how a treatment performs in a lab, but how it works in real life," he says.

Making Safety a Priority

Modern therapies have improved outcomes dramatically. But side effects remain a serious concern. HER2-targeting agents, for instance, can affect heart function. Hormone therapies may trigger joint pain, mood changes, or bone density loss.

That's why Dr. Agarwal stresses the importance of integrating safety into every stage of research. From cardiac screening before enrollment to long-term quality-of-life monitoring, a proactive approach is essential.

"Supportive care is part of the treatment, not something separate from it," he says.

Building a Better Research Model

With survival rates improving, the next frontier in breast cancer research is making sure patients also thrive. That means shifting how trials are designed, what they measure, and who they include.

For Dr. Sud Agarwal and the team at iNGENū CRO, the mission is clear: build trials that reflect the lives of the people they're meant to help.

"We have better data and better tools than ever before," he says. "Now we need to build better questions—and better answers—for the future of breast cancer care."

Original Publication: https://www.youthhealthmag.com/articles/53798/20250804/rethinking-breast-cancer-trials-a-clinical-perspective-from-dr-sud-agarwal-ceo-of-ingen%C5%AB-cro.htm