Streamlining care through patient navigation: a retrospective cohort study of timely anti-HER2 therapy in early breast cancer in a low-middle income country

Shash et al. BMC Health Services Research (2025) 25:1454 https://doi.org/10.1186/s12913-025-13606-8 BMC Health Services Research Open Access RESEARCH Streamlining care through patient navigation: a retrospective cohort study of timely antiHER2 therapy in early breast cancer in a lowmiddle income country Emad Shash1,2*, Fatema Alaa3, Engy Maher3, Julia F. Rostom3, Alaa Ibrahim3, Rania Said3, Nada Abou El-Kheir3, Mona Elhosary3 and Reem Eid2,4 Abstract Background Timely initiation of therapy is critical for patients with HER2-positive early breast cancer, especially in low- and middle-income countries (LMICs) where health-system constraints delay care. We evaluated whether a Patient Navigation Program could reduce time from registration to initiation of dual anti-HER2 therapy in Egypt. Methods Retrospective cohort study at the Breast Cancer Comprehensive Center (BCCC). Trained navigators tracked diagnostics, scheduled multidisciplinary tumor board (MDT), prepared/submitted Ministry of Health (MOH) approval files, monitored approval, and booked the earliest infusion slot. The primary endpoint was time from registration to therapy start; secondary endpoints were prespecified intervals—T1 (registration→MDT), T2 (MDT→MOH submission), T3 (MOH submission→MOH approval), and T4 (MOH approval→therapy start), time to surgery, and pathological complete response (pCR). The primary analysis compared symmetric six-month windows: July–December 2022 (without navigation) vs. January–June 2023 (with navigation). A sensitivity analysis included all eligible patients: May– December 2022 vs. January–December 2023. Two-sided p < 0.05 was significant. Results In the primary analysis, navigation significantly shortened MOH approval → therapy start (T4) (p = 0.008), while T1–T3 and total time showed non-significant differences (total: p = 0.127). pCR was similar (78/115 [67.8%] vs. 81/117 [69.2%], p = 0.818). In the sensitivity analysis (N = 441), total time decreased from 146.2 ± 76.6 to 121.6 ± 50.4 days (–24.6 days, p < 0.001), driven by a large improvement in T4 (32.4→20.8 days; − 11.6 days, p < 0.001) while pCR remained comparable, although not statistically significant (64.1% vs. 69.9%, p = 0.76). Conclusion In an LMIC tertiary center, a Patient Navigation Program significantly accelerated the post-approval step to treatment and, across the full year, shortened the overall time from registration to initiation of dual anti-HER2 therapy despite rising volumes. These system-level gains, support navigation as a scalable, equity-promoting strategy aligned with World Health Organization (WHO)Global Breast Cancer Initiative priorities; prospective multicenter evaluations incorporating patient-reported outcomes and cost-effectiveness are warranted. *Correspondence: Emad Shash Full list of author information is available at the end of the article © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Shash et al. BMC Health Services Research (2025) 25:1454 Page 2 of 8 Keywords Breast cancer, HER2-positive, Dual HER2 blockade, Patient navigation, Treatment delay, Low- and middleincome country (LMIC) Background Breast cancer is the most diagnosed cancer and the leading cause of cancer death among women globally [1]. In 2020, an estimated 2.3 million new cases and 685,000 deaths were reported, with a disproportionate burden in low- and middle-income countries (LMICs) where constrained systems drive later diagnosis and treatment delays [1, 2]. Timely therapy is critical: longer intervals to treatment are consistently associated with more advanced disease at presentation and poorer survival [3–5]. Human epidermal growth factor receptor 2 (HER2)– positive breast cancer is biologically aggressive but highly curable when modern therapy is delivered without delay. In the neoadjuvant setting, dual HER2 blockade (trastuzumab plus pertuzumab) with chemotherapy significantly increases pathological complete response (pCR) versus chemotherapy alone or single-agent HER2 targeting [6]. Because pCR correlates with lower recurrence and improved survival, delays in initiating HER2-targeted treatment may compromise the probability of cure. At the Breast Cancer Comprehensive Center (BCCC), National Cancer Institute, Cairo University (Cairo, Egypt), the standard pathway for HER2-positive early breast cancer includes neoadjuvant chemotherapy plus dual anti-HER2 therapy (trastuzumab + pertuzumab), definitive surgery, and adjuvant systemic therapy and/or radiotherapy as indicated. Within the public sector, starting dual anti-HER2 therapy requires Ministry of Health (MOH) approval based on a complete dossier (histopathology/receptor status and baseline assessments). This administrative step, alongside communication gaps and patient-level barriers (navigating appointments, document acquisition, health literacy), can introduce clinically meaningful delays—challenges echoed in other Egyptian public cancer centers. Egypt’s Presidential Initiative for Women’s Health (launched 2019) has expanded screening and access; by March 2022, >16.5 million women had been screened, and the government committed to providing innovative cancer therapies free of charge to eligible patients [7]. Realizing these gains, however, depends on parallel improvements in care coordination after diagnosis. Patient navigation is an established strategy to reduce delays and inequities. Originating in 1990 at Harlem Hospital, navigation for underserved patients substantially improved breast cancer outcomes (five-year survival ~ 70% with-navigation versus 39% without) [8]. Across diverse settings, navigators—nurses, social workers, or trained laypersons—coordinate appointments, facilitate communication, and resolve logistical barriers, shortening time from abnormality to diagnosis and from diagnosis to treatment, particularly for vulnerable groups [9–15]. International bodies, including the Breast Health Global Initiative (BHGI) and WHO, endorse navigation as part of comprehensive cancer control in LMICs [15]. Aligned with these directives, the Breast Cancer Comprehensive Center (BCCC) established a dedicated Patient Navigation Program in 2022, (...truncated)