A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Quality of Life (QOL), Toxicities, Breast Diseases. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)
Overview
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.
Detailed description
PERSEVERE is a prospective, multi-modal cohort study designed to evaluate treatment-related toxicities and quality of life in people with stage I-III early breast cancer receiving local therapy in China. Participants will be eligible if they either:
Receive neoadjuvant therapy (such as chemotherapy or targeted therapy) prior to surgery, or
Undergo surgery followed by postoperative adjuvant therapy, including chemotherapy, radiotherapy, endocrine therapy, or targeted therapy.
The study does not include individuals with recurrent or metastatic breast cancer.
Study Objectives and Methods This study aims to understand the short- and long-term physical, psychological, and social effects of breast cancer treatment and how they impact participants' recovery and daily life.
At baseline, the study collects comprehensive information on participants':
Sociodemographic status: marital status, education level, and household income
Anthropometric measurements: height, weight, body mass index (BMI), waist and hip circumference
Medical history: personal medical history, comorbidities, and past treatments
Reproductive history: menstrual and fertility history
Participants also undergo baseline clinical assessments, including:
Echocardiography (e.g., LVEF) to screen for cardiotoxicity
Pulmonary function testing, conducted for participants aged 70 or older
Routine laboratory tests, such as liver and kidney function, lipid metabolism, and inflammation markers
Biospecimens collected at baseline include:
Peripheral blood (plasma and PBMCs)
Tumor and adjacent normal tissue from surgery
These samples are stored for future biomarker discovery, multi-omics analyses, and translational research on treatment-related toxicities.
Following baseline assessments, participants complete a series of validated patient-reported outcome (PRO) questionnaires, which provide insight into their physical symptoms, emotional well-being, and quality of life. These include:
EORTC QLQ-C30 and QLQ-BR23 for cancer-related quality of life
HADS (Hospital Anxiety and Depression Scale)
Pittsburgh Sleep Quality Index (PSQI) for sleep disturbances
Brief Pain Inventory - Short Form (BPI-SF)
Perceived Stress Scale (PSS-10) for psychological stress
Social Support Rating Scale (SSRS) for social support assessment
Follow-up and Data Collection
Participants are followed using standardized electronic questionnaires administered via the REDCap platform at:
Postoperative week 1, month 1, month 3, and every 6-12 months thereafter for up to 5 years
No repeat biospecimen or clinical tests are collected after baseline. Follow-up focuses on tracking changes in symptoms and quality of life through PROs, enabling analysis of individual recovery trajectories.
Quality Assurance Data collection uses REDCap with built-in logic and range validation
A structured data dictionary ensures consistency across sites
SOPs guide recruitment, consent, biospecimen handling, adverse event reporting, and data entry
Source data verification will be conducted on a sample of participants
Missing data will be managed using statistical imputation and sensitivity analysis
Study Innovation and Impact
PERSEVERE is one of the first large-scale prospective cohort studies in China specifically focused on treatment-related toxicities and quality of life in breast cancer patients. It is designed to:
Capture a comprehensive picture of treatment-related toxicities, beyond acute effects
Enable integrative analysis of biological, physical, and psychological indicators
Build a clinical-biological dataset for developing prediction tools and AI-driven recovery models
Guide personalized supportive care strategies based on Chinese breast cancer patients' needs
Interventions
- Procedure blood 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.
Primary outcome measures
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Baseline, 1week, 1 month, 3 months, 6 months, 12 months, annually up to 5 years]
Secondary outcome measures (1)
- Trajectories and Risk Factors for Cancer-Related Fatigue Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue Module (EORTC QLQ-FA12) [Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months, then annually up to 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Beijing
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen
- Shanxi Cancer Hospital — Taiyuan
Publications
- Qu Z, Wang H, Li Q, Zhang Y, Li K, Pei S, Yang Y, Zhang L, Yang X, Wang J, Fang Y. PERSEVERE: longitudinal assessment of quality of life and treatment toxicities in Chinese breast cancer patients - a multicentre cohort study protocol. BMJ Open. 2026 Apr 1;16(4):e115797. doi: 10.1136/bmjopen-2025-115797. PMID 41922058
Identifiers
NCT: NCT07010939 · 245194799