Retrospective Assessment of Pertuzumab Therapy in Real-World Settings for the Management of HER2-Positive Breast Cancer: Clinical Characteristics and Treatment Outcomes.

This study looks into how to treat breast cancer in India better, where 192,020 new cases were reported 2022. The study focuses on a type of metastatic breast cancer, a specific subgroup of HER2-positive metastatic breast cancer, which is quite common. Right now, one of the approved drug combinations is trastuzumab and pertuzumab to treat it, but there are not enough studies to see how it works in real life for Indian patients. So, the current study intends to see if combining pertuzumab with trastuzumab is safe and helpful for these patients. The study will focus on the patient’s life expectancy as well as the survival without disease progression. Also, it will evaluate how effectively patients respond to the treatment and if side effects occur. The study will also try to understand the efficacy of the standard treatment.  The study will look at information from patients treated at Tata Memorial Hospital or the Advanced Centre for Treatment, Research, and Education in Cancer (ACTREC) between January 1, 2013, and March 31, 2024, in Mumbai.

This research study lies in the need to evaluate the real-world effectiveness and safety profile of Pertuzumab therapy in conjunction with Trastuzumab for the treatment of HER2-positive breast cancer patients in the Indian population. Although the efficacy of this combination has been established in clinical trials, there is a lack of data on its impact on overall survival (OS) and progression-free survival (PFS) specifically within the Indian context, Non-metastatic, metastatic, adjuvant and neoadjuvant settings. This gap in data may be attributed to the high cost of Pertuzumab, limiting accessibility for many patients in developing countries like India, which in turn restricts research opportunities.

The study focuses on assessing OS and PFS as critical measures of treatment efficacy and patient outcomes. Additionally, it aims to characterize patient demographics, disease status, treatment history, and follow-up data to provide a thorough understanding of treatment responses. Given that existing real-world studies on this therapy predominantly cover other populations, there is a need to explore its effects within the Indian population.

Furthermore, the study intends to analyse treatment patterns, including dosing regimens and duration, to understand how Pertuzumab is utilized in routine clinical practice. This analysis will provide a better understanding of how the treatment is currently being used and identify areas where it could be improved. By evaluating treatment responses and outcomes, including OS, PFS, and toxicities, the study will assess the effectiveness and safety of Pertuzumab in real-world settings.

Conducting this study at centers like TMH and ACTREC, which handle a large number of patients, is feasible and provides an opportunity to gather significant data. Ultimately, this research aims to bridge the gap between clinical trial data and everyday clinical practice, enhancing understanding of Pertuzumab’s role in managing HER2-positive metastatic breast cancer. The findings could guide clinicians in developing treatment strategies, potentially leading to improved clinical outcomes and quality of life for patients.