RecruitingNCT07010939

A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer Patients

A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)

Sponsor

FangYi

Enrollment

3,000 participants

Start Date

Apr 7, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms Breast Diseases Quality of Life (QOL)Toxicities

Summary

This study, called PERSEVERE, examines how local treatment for early breast cancer affects people's health and daily lives over time. People who join the study will have early-stage breast cancer and receive treatment such as surgery and other therapies that are used before or after surgery. The study does not include people with late-stage (metastatic) breast cancer. Researchers want to learn about short- and long-term side effects that can happen during or after treatment. These may include tiredness, trouble sleeping, emotional distress, pain, or changes in heart or lung function. The study also looks at how these effects impact participants' quality of life. Participants will be asked to complete surveys about how they feel. They will also have health checks, such as heart tests, lung function tests, and blood samples. Tissue samples from surgery will also be collected. The goal is to understand better how different people respond to breast cancer treatment and find ways to support long-term recovery.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the side effects and quality of life of Chinese women with breast cancer who are receiving local treatments — such as surgery, chemotherapy, radiation, hormone therapy, or targeted therapy — over time. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with stage I, II, or III invasive breast cancer (confirmed by biopsy or lab test) - There is no evidence the cancer has spread to other parts of the body - You are scheduled to receive surgery and/or other breast cancer treatments - You are willing to complete health questionnaires and attend follow-up visits **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You have already completed all treatment - You are unable or unwilling to provide consent or attend follow-ups Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREblood sampling

At baseline, participants will undergo peripheral blood collection using EDTA tubes. A total of 10 mL of venous blood will be collected and processed into plasma and peripheral blood mononuclear cells (PBMCs). Plasma samples will be stored at -80°C, and PBMCs will be cryopreserved in liquid nitrogen. These samples will be used for future biomarker discovery, multi-omics analysis, and studies of biological mechanisms underlying treatment-related toxicities.

Locations(3)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT07010939

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