Targeted Therapies in Women’s Oncology: A New Era of Personalized Care

The field of women’s oncology is undergoing one of its most transformative periods, driven by the rapid advancement of novel and targeted therapies. Treatment approaches are no longer “one-size-fits-all;” instead, care is increasingly guided by underlying tumor biology, enabling more precise alignment of therapies with individual patient needs. This shift has led to more durable responses, improved survival rates, and, in some cases, reduced side effects—particularly in breast, ovarian, and endometrial cancers.   

This blog highlights how evolving therapies are transforming women’s cancer care and underscores the critical role of trial planning, from rigorous site training and clear eligibility criteria to centralized monitoring applications and patient involvement.  

The shift to precision  

Historically, women with recurrent endometrial cancer had limited treatment options, often relying on traditional chemotherapy with modest benefit and substantial toxicity. Today, biomarker-driven therapies are changing that trajectory. Advances in molecular profiling now enable the development of treatments targeted to specific tumor characteristics, offering more personalized care and improved clinical outcomes. This shift toward precision not only enhances efficacy but also informs smarter clinical trial design—ensuring the right patients receive the right therapies at the right time.  

Novel approaches redefining women’s cancer treatment  

Let’s take a closer look at some of the most promising innovations in this space:  

CAR T-cell therapy  

Originally a breakthrough in hematological cancers, CAR-T therapy is now being explored in aggressive forms of breast and ovarian cancer. It involves engineering a patient’s own T-cells to recognize and destroy cancer cells. Although this therapy holds immense potential, it also carries serious toxicity risks like cytokine release syndrome (CRS) and neurotoxicity, making careful patient monitoring essential.  

Antibody-drug conjugates (ADCs)  

ADCs deliver a precise dose of chemotherapy directly to cancer cells using an antibody as a guide. FDA-approved ADCs such as trastuzumab deruxtecan have already improved survival rates in HER2-positive breast cancer. However, they come with their own risks, including pneumonitis and cytopenias, and require vigilant oversight.  

Radiopharmaceuticals  

This growing field involves attaching radioactive particles to molecules that target cancer cells. It’s particularly promising in ovarian and endometrial cancers. The key challenge lies in precision—delivering enough radiation to the tumor while minimizing harm to healthy tissue.  

Across these modalities, the common theme is personalization—using science to bring smarter, safer, and more effective treatments to women with cancer.  

Clinical trial execution: Precision requires preparation  

Behind every breakthrough therapy is a robust clinical trial infrastructure. Effective site training is foundational. It’s critical that investigators clearly understand inclusion and exclusion criteria—especially in trials involving CAR-T therapies, where patients with autoimmune disorders or organ dysfunctions are often excluded.  

Ongoing education is just as important as initial training. Digital tools like interactive videos and quizzes help keep sites compliant as protocols evolve.  

Managing unique toxicities  

Each novel therapy comes with its own set of challenges:  

• CAR-T: Toxicities such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) require rapid recognition and intervention. We arm sites with quick-reference guides to help teams act fast when every minute counts.  

• ADCs: Although designed to minimize systemic toxicity, antibody-drug conjugates (ADCs) can lead to unexpected side effects. In one case involving a patient with HER2-positive breast cancer, the onset of blurry vision was initially considered unrelated. Further evaluation revealed early-stage keratitis, a known but rare toxicity associated with ADCs.   

These challenges underscore the importance of preparing sites to recognize and respond to even subtle symptoms.  

Balancing safety and efficacy 

Dose escalation trials must balance therapeutic impact with patient safety. In one study, a patient with ovarian cancer developed severe neutropenia. Following CTCAE guidelines, the study drug dose was reduced, symptoms were monitored, and the dose was safely re-escalated. Achieving this balance requires clinical judgment and a clear understanding of toxicity grading systems.  

Centralized monitoring: Enhancing oversight  

The COVID-19 pandemic accelerated the adoption of centralized monitoring, which now plays a key role in trial oversight. At Premier, our Remarque platform blends traditional CTMS functionality with risk-based monitoring, helping us flag issues—like clusters of ADC-related pneumonitis, for example—before they escalate.  

With cross-functional teams analyzing real-time data, site performance concerns can be identified early and corrective actions can be implemented swiftly, keeping trials on track and ensuring patient safety.  

The power of patient voices  

Patient-reported outcomes (PROs) are invaluable in understanding the true impact of therapies. Unlike clinician observations, PROs come directly from the patient—capturing critical quality-of-life data that often goes unreported. In a CAR-T trial, PRO data helped identify early neurological symptoms before they became serious. In another case, subtle vision changes reported through a PRO platform led to early intervention for ocular toxicity.  

Beyond clinical benefit, PROs also support drug valuation and reimbursement decisions, especially as payers increasingly look to real-world data to assess cost-effectiveness.  

Meeting scientific advancement with compassionate care  

The evolution of women’s oncology is being driven by precision science, smarter clinical execution, and a growing respect for the patient voice. As the field advances with complex modalities such as cell therapy and targeted agents, success increasingly depends on trials that are efficient, inclusive, and aligned with real-world patient needs. Strategic focus on site readiness, data integrity, and patient-centric design is essential to translating innovation into impact. The future of women’s cancer care will be shaped by those who can unite scientific progress with operational excellence.  

At Premier Research, our mission is to partner with sites, support patients, and bring the next generation of therapies to life—safely, effectively, and with empathy.  

For support with your next women’s oncology trial, contact us.  

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.