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

Inclusion Criteria8

Women aged 18 years or older
Diagnosed with stage I, II, or III invasive breast cancer confirmed by pathology or cytology
No signs of metastatic disease (cancer that has spread to other parts of the body)
Scheduled to receive local treatment, including:
Surgery
And/or neoadjuvant or adjuvant therapy such as chemotherapy, radiation, hormone therapy, or targeted therapy
Willing and able to complete health questionnaires and attend follow-up visits
Has given written informed consent to join the study

Exclusion Criteria5

Have metastatic breast cancer or local recurrence
Have already received curative treatment (surgery, chemo, etc.) for the current breast cancer before joining the study
Are currently pregnant or breastfeeding
Have a history of another cancer within the past 5 years (except for non-melanoma skin cancer or in-situ cervical cancer)
Are unable to participate in the study due to mental, physical, or legal reasons (for example, under legal guardianship or imprisonment)

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.