Introduction
Timely initiation of anti-HER2 therapy is crucial for improving outcomes in patients with HER2-positive early breast cancer. In low- and middle-income countries (LMICs), health-system constraints—ranging from diagnostic delays to limited access to targeted therapies—can hinder timely treatment. This retrospective cohort study examines whether a structured Patient Navigation Program can streamline care, reduce delays, and improve the timely delivery of anti-HER2 therapy in an LMIC setting.
Background and Rationale
HER2-positive breast cancer accounts for a substantial portion of early-stage cases where targeted anti-HER2 therapy (such as trastuzumab) markedly improves disease-free survival. Yet, in LMICs, bottlenecks in referral pathways, appointment scheduling, diagnostic confirmation, and treatment initiation frequently lead to suboptimal timing. Patient navigation—a model that assigns a trained navigator to guide patients through complex care pathways—has shown promise in other diseases by coordinating appointments, reducing no-show rates, and addressing financial and logistical barriers. This study evaluates the real-world impact of such a program on time-to-treatment metrics and patient outcomes.
Methods
We conducted a retrospective cohort study at a tertiary hospital serving a mixed urban-rural population in a middle-income country. The study included adults diagnosed with HER2-positive early breast cancer who were eligible for anti-HER2 therapy. The cohort was divided into two groups: (1) patients who received care with the support of a dedicated Patient Navigation Program, and (2) patients who received standard care without navigational support. Key outcomes included time from diagnosis to initiation of anti-HER2 therapy, rates of neoadjuvant vs. adjuvant therapy, and treatment completion. We also tracked 12-month disease-free survival and overall survival as exploratory endpoints. Data were drawn from medical records, tumor boards, and pharmacy dispensing logs over a 36-month period.
What the Navigation Change Looks Like in Practice
The Patient Navigation Program implemented several core components designed to shorten care pathways:
- Structured appointment scheduling and reminders to reduce missed visits.
- Timely diagnostic workups, including pathology confirmation and HER2 testing.
- Streamlined referral processes to ensure rapid access to medical oncology and targeted therapy.
- Assistance with financial counseling, transportation support, and social work referrals to mitigate economic barriers.
- Regular progress reviews with a multidisciplinary team to anticipate and resolve bottlenecks.
Navigators served as a consistent point of contact for patients, family members, and care teams, aligning clinical milestones with practical support. The program was designed to minimize delays while preserving clinical judgment and patient autonomy.
Key Findings
Compared with standard care, the navigator-supported cohort demonstrated a statistically significant reduction in time from diagnosis to initiation of anti-HER2 therapy. The median time-to-therapy decreased by several weeks, bringing more patients within guideline-recommended timeframes. In addition, higher completion rates of planned anti-HER2 regimens were observed, with fewer dropouts due to logistical barriers.
Exploratory analyses suggested a trend toward improved 12-month disease-free survival in the navigator group, though longer follow-up is required to confirm durable oncologic benefits. Importantly, the program did not increase overall treatment costs when considering avoided delays, reduced hospital readmissions due to miscoordination, and decreased patient dropouts.
Implications for LMIC Health Systems
This study highlights that patient navigation can be an effective, scalable strategy to streamline cancer care in resource-constrained settings. By addressing non-clinical barriers—such as transportation, appointment logistics, and financial toxicity—navigators help ensure that timely anti-HER2 therapy is accessible to a larger segment of patients. Health systems facing shortages in oncologists, diagnostic services, and essential drugs can particularly benefit from structured navigation to optimize existing resources and improve equity of access.
Limitations and Future Directions
As a retrospective single-center analysis, findings may not be generalizable to all LMIC contexts. Confounding factors, such as baseline patient characteristics and variations in tumor biology, could influence results. Prospective, multicenter trials are needed to validate the effectiveness of patient navigation, quantify its cost-effectiveness, and explore integration with telemedicine and digital health tools to extend reach in rural areas.
Conclusion
Implementing a Patient Navigation Program in an LMIC setting appears to shorten the time to initiate anti-HER2 therapy for early breast cancer and improve adherence to treatment. With careful design, training, and collaboration across oncology, nursing, social work, and administration, navigation can be a practical path to more timely, equitable cancer care—and a meaningful step toward closing gaps in cancer outcomes in low- and middle-income countries.
