Real-world efficacy and safety of neoadjuvant TCHP in HER2-positive non-metastatic breast cancer in a government tertiary care center in India.

Abstract

e12643 Background: Randomized trials support Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) in HER2-positive breast cancer; however, real-world evidence from low- and middle-income countries and public-sector hospitals remains limited. Following the introduction of generic Trastuzumab and Pertuzumab in India, access to dual HER2 blockade has expanded in government healthcare systems. This study presents the first Indian government-sector real-world evaluation of neoadjuvant TCHP. Methods: We conducted a retrospective cohort study of 53 patients with non-metastatic HER2-positive breast cancer treated with neoadjuvant TCHP at a tertiary government hospital between 2019 and 2025. The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Toxicity was graded using CTCAE v5.0. Exact 95% confidence intervals (CI) were calculated using the Clopper–Pearson method, and Fisher’s exact test compared pCR rates between hormone receptor (HR) subgroups. Results: Of 53 patients, 24 (45.3%) were HR-positive and 29 (54.7%) HR-negative. Stage distribution was 2 (3.8%) stage I, 14 (26.4%) stage II, and 38 (71.7%) stage III. The overall pCR rate was 58.5% (31/53; 95% CI, 44.1–71.9%).pCR rates were consistent across subgroups. By HR status, pCR occurred in 54.2% (13/24; 95% CI, 32.8–74.4%) of HR-positive and 62.1% (18/29; 95% CI, 42.3–79.3%) of HR-negative tumors (p = 0.587). By clinical stage, pCR was achieved in 50.0% (1/2; 95% CI, 1.3–98.7%) of stage I, 57.1% (8/14; 95% CI, 28.9–82.3%) of stage II, and 57.9% (22/38; 95% CI, 40.8–73.7%) of stage III patients, demonstrating preserved efficacy despite advanced disease.Treatment adherence was 96.2% (51/53). Grade 3 diarrhea occurred in 7.5% and Grade 2 neutropenia in 5.7%. No Grade 4 toxicities or treatment-related deaths occurred. Conclusions: This first Indian government-sector real-world study demonstrates that neoadjuvant TCHP in the post-generic HER2-therapy era achieves high and consistent pCR across HR and stage subgroups, including a cohort predominantly composed of stage III disease. Outcomes were comparable to pivotal international trials, with high treatment completion and acceptable toxicity. These findings support scalable implementation of dual HER2-targeted neoadjuvant therapy in public healthcare systems, with relevance for resource-constrained oncology settings globally.