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Breast Cancer Treatment Studies / HER2/EGFR in Cancer Research / Advanced Breast Cancer Therapies · Journal article
Frontiers in Oncology · September 9, 2026
Reinforces what was already believed, rather than introducing something new.
This single-centre, real-world cohort of 74 Indian patients with HER2-positive breast cancer achieved a pCR rate of 51.4% with neoadjuvant dual HER2 blockade (pertuzumab and trastuzumab), consistent with historical trial results. Tumour and composite clinical stage independently predicted response; SC and IV administration showed comparable efficacy and safety, with anemia and hepatic toxicity as the most common adverse events.
Ambispective (retrospective and prospective) descriptive real-world cohort study. Patients with HER2-positive early breast cancer receiving neoadjuvant dual HER2 blockade (pertuzumab and trastuzumab) at KIMSHEALTH, Trivandrum, Kerala. Mean age 56.8 ± 9.1 years.. Intervention: Intravenous or subcutaneous pertuzumab and trastuzumab (dual HER2 blockade) as neoadjuvant therapy. Compared with: Comparison between SC (n=52) and IV (n=22) administration; no external control arm. n = 74. KIMSHEALTH, Trivandrum, Kerala, India (single centre).
Overall pCR rate was 51.4% (52.0% in 74 patients) SC dual HER2 blockade achieved pCR rate of 44.2% (n=52); IV achieved 68.2% (n=22), difference not significant (p=0.06) Tumour stage (p=0.044) and composite clinical stage (p=0.019) significantly associated with pCR; estrogen receptor status not associated (p=0.064)
Anemia and hepatic toxicity were most common treatment-related toxicities; comparable safety between SC and IV groups
Clinicians can reasonably expect a ~50% pCR rate with dual HER2 blockade in real-world Indian practice, consistent with trial data. The finding of comparable efficacy and safety between SC and IV administration supports either formulation as a practical choice, though the small sample and non-significant p-value (0.06) for the SC/IV comparison warrant caution in drawing strong conclusions about equivalence.
Real-world observational study confirming efficacy of dual HER2 blockade in neoadjuvant HER2-positive breast cancer, consistent with historical trial data but limited by small single-centre sample and descriptive design.
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Clinicians can reasonably expect a ~50% pCR rate with dual HER2 blockade in real-world Indian practice, consistent with trial data. The finding of comparable efficacy and safety between SC and IV administration supports either formulation as a practical choice, though the small sample and non-significant p-value (0.06) for the SC/IV comparison warrant caution in drawing strong conclusions about equivalence.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Introduction Breast cancer (BC) is the most commonly diagnosed malignancy among women globally and in India. The human epidermal growth factor receptor 2 (HER2)-positive subtype is associated with aggressive disease and poorer prognosis; however, neoadjuvant therapy combining dual HER2 blockade with chemotherapy has been shown to improve pathological complete response (pCR) rates. This study evaluated the real-world effectiveness of dual HER2 blockade in the Indian setting. Methods This ambispective, descriptive real-world study was conducted at KIMSHEALTH, Trivandrum, Kerala (1 October 2019–30 April 2025), comprising retrospective (1 October 2019–30 April 2024) and prospective (1 May 2024–30 April 2025) phases. Patients with HER2-positive early BC receiving intravenous (IV) or subcutaneous (SC) pertuzumab and trastuzumab were included. The primary endpoint was pCR. Secondary endpoints included comparison of pCR between the IV and SC groups; assessment of chemotherapy regimen, disease stage, and hormonal status on outcomes; and evaluation of treatment-related toxicities. Results A total of 74 patients (35: retrospective; 39: prospective) (mean age: 56.8 ± 9.1 years) were included in the study; 52 (70.3%) received SC, and 22 (29.7%) received IV dual HER2 blockade. The overall pCR rate was 51.4% (SC: 44.2%; IV: 68.2%; p=0.06). Tumor stage (p=0.044) and composite clinical stage (tumor, node, and metastasis) (p=0.019) were significantly associated with pCR in the overall population, whereas estrogen receptor (ER) status was not associated with pCR (p=0.064). Multivariate analysis identified the composite clinical stage as an independent predictor of pCR (odds ratio: 0.242; p=0.012). Anemia was the most common toxicity, followed by hepatic toxicity, with comparable safety between the SC and IV groups. Discussion Neoadjuvant dual HER2 blockade in HER2-positive BC is effective and well tolerated in the Indian real-world setting, with tumor stage and composite clinical stage significantly influencing response, while ER status showed no significant association with pCR. SC and IV dual HER2 blockade demonstrated comparable efficacy and safety outcomes. These findings, which are consistent with historical data, further reinforce the therapeutic advancement from trastuzumab-based therapy to dual HER2 blockade, highlighting its improved effectiveness and clinical importance in the neoadjuvant treatment of HER2-positive BC.
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