The PERFORM (Personalized Exercise-Rehabilitation For people with Multiple long-term conditions (multimorbidity)) study is a noninterventional, open-label trial that aims to assess the efficacy and patient-reported outcomes of palbociclib in combination with endocrine therapy as first-line treatment for patients with advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2negative (HER2-) breast cancer in a real-world setting. This study will provide valuable insights into current treatment patterns, patient characteristics, and the effectiveness of palbociclib in everyday clinical practice.
Introduction
Breast cancer is a prevalent health issue, with over 2.3 million new cases diagnosed worldwide each year [1]. Despite significant advances in surgical and medical treatments, advanced HR+/HER2- breast cancer remains a challenge, and effective systemic therapies are needed to improve patient outcomes.
Palbociclib is an inhibitor of CDK4 and CDK6, which are key drivers of cell cycle progression. Recent clinical trials have demonstrated that palbociclib in combination with endocrine therapy can significantly improve progression-free survival (PFS) in patients with HR+/HER2- advanced breast cancer [2][3]. However, the true efficacy and impact of palbociclib in the real world are not yet fully understood.
The PERFORM study will investigate the effectiveness of palbociclib when used in combination with endocrine therapy in a diverse population of patients with advanced HR+/HER2- breast cancer. This study will also explore patient-reported outcomes, such as quality of life and symptoms, which are crucial for understanding the full impact of treatment on patients' lives.
Methods
Design and Participants
The PERFORM study is a noninterventional, open-label trial that will recruit participants from German and Austrian medical practices. Inclusion criteria include age ≥18 years, histologically confirmed HR+/HER2- breast cancer, ≥2 previous lines of systemic therapy for advanced disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion criteria includeprevious参与者 must not have received prior treatment with CDK4 or CDK6 inhibitors, radiotherapy within the past 4 weeks, or any other concurrent cancer treatment.
interventions
Eligible participants will receive palbociclib 150 mg oral capsules once daily continuously in combination with endocrine therapy, which can include aromatase inhibitors or fulvestrant, per standard of care. The duration of the study will be ≤2 years, with follow-up visits every 3 months for the first year and every 6 months thereafter.
Outcomes
The primary effectiveness endpoint is PFS, defined as the time from randomization to objective disease progression or death from any cause. Secondary endpoints include objective response rate (ORR), duration of response, time to next treatment, safety and tolerance, and changes in patient-reported outcomes.
Discussion
The PERFORM study will provide important information on the efficacy and safety of palbociclib in a real-world setting. By incorporating data from a diverse population of patients with advanced HR+/HER2- breast cancer, the study will help to fill the knowledge gaps regarding the effectiveness of palbociclib in clinical practice. Additionally, the study will assess patient-reported outcomes, which can provide valuable insights into the impact of treatment on patients' quality of life and overall well-being.
Funding and Collaboration
This project is funded by the National Institute for Health Research (NIHR) Programme Grants. The study is co-developed with patients, caregivers, clinicians, and service commissioners to ensure that the research program is grounded in the experiences and perspectives of those affected by the condition.
##The PERFORM study will provide valuable insights into the effectiveness and safety of palbociclib in combination with endocrine therapy in the treatment of advanced HR+/HER2- breast cancer. By including a broad range of patients and assessing both efficacy and patient-reported outcomes, the study will contribute to the knowledge base surrounding this treatment option and inform future clinical practice.
Acknowledgements
The authors would like to thank all participants, caregivers, and clinical staff who contributed to the success of the PERFORM study.
References
- [1] data. [2]研究者. (年份). N Engl J Med. DOI: 10.1056/NEJMoa1XXYY. [3]研究者. (年份). J Clin Oncol. DOI: 10.1200/jco.XXXXX.
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