Dr Punie on Patient-Reported Outcomes With Sacituzumab Govitecan vs Chemotherapy in Advanced TNBC

“When considering the baseline scores, it is always important in this type of study to assess baseline quality-of-life measures. In this trial, baseline quality of life was well balanced between the experimental and control arms. However, when compared with population-level reference values, several domains—such as physical functioning and role functioning—showed lower baseline scores, indicating clear room for improvement. This observation contributed to the rationale for including time to improvement as an exploratory PRO end point in the study.”

Kevin Punie, MD, a medical oncologist in the Department of General Medical Oncology at University Hospitals Leuven, Gasthuisberg, discussed patient-reported outcomes (PROs) from the phase 3 ASCENT-03 trial (NCT05382286), which compared sacituzumab govitecan-hziy (Trodelvy) with physician’s choice of chemotherapy in patients with previously untreated advanced triple-negative breast cancer (TNBC) who were not candidates for PD-(L)1 inhibitors.

He noted that the PRO findings complement the clinical efficacy and safety results from the study, offering important insights into patient experience during treatment.

In ASCENT-03, PROs were prespecified as key secondary end points, reflecting the substantial symptom burden and functional decline typically observed in advanced TNBC. Punie explained that two PRO measures were prioritized for hierarchical testing: time to deterioration in fatigue and mean change from baseline to week 25 in physical functioning using the EORTC QLQ-C30 scale. These domains were selected because fatigue and physical impairment are among the most clinically meaningful and frequently reported concerns for this population.

Beyond these key end points, investigators conducted extensive exploratory analyses, including mean change from baseline to week 25 across all QLQ-C30 domains, time to deterioration in each domain, time to confirmed deterioration, and time to improvement. Patients completed questionnaires at baseline and on day 1 of each treatment cycle until end of treatment, enabling a longitudinal assessment of symptom burden and functional impact.

Punie noted that baseline quality-of-life scores were well balanced between SG and control arms, supporting validity of comparative analyses. Importantly, several domains—particularly physical functioning and role functioning—were lower than reference population norms at study entry.

Although detailed numerical results were not included in this summary, Punie highlighted that the PRO data presented at the 2025 San Antonio Breast Cancer Symposium further contextualize the clinical activity of sacituzumab govitecan by illustrating how patients perceived fatigue, physical functioning, and other quality-of-life dimensions throughout treatment. These findings may inform shared decision-making and patient counseling, particularly in a population for whom symptom burden, treatment tolerability, and preservation of daily functioning are critical considerations.

Ultimately, Punie emphasized that incorporation of robust, longitudinal PRO assessment into ASCENT-03 provides an important patient-centered perspective that complements traditional oncologic end points and supports ongoing evaluation of sacituzumab govitecan in first-line TNBC settings.