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

NCT ID: NCT07010939

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2028-12-31

Brief 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.

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

The findings will provide new insights into survivorship and recovery and help clinicians deliver evidence-based, patient-centered care.

Conditions

Breast Neoplasms; Quality of Life (QOL); Toxicities; Breast Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early-Stage Breast Cancer Patients Receiving Local Therapy

This group includes people diagnosed with stage I to III breast cancer who are receiving local therapy with curative intent. Local therapy in this study includes surgery, as well as systemic treatments given before or after surgery, such as:

Neoadjuvant therapy (for example, chemotherapy or targeted therapy given before surgery)

Adjuvant therapy (for example, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given after surgery)

This is an observational study. There is no experimental intervention. All participants will undergo baseline assessments, including clinical evaluations, laboratory tests, patient-reported outcome questionnaires, and biospecimen collection. Participants will then be followed over time to monitor treatment-related toxicities and changes in quality of life.

blood sampling

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

FangYi

OTHER

Sponsor Role: lead

Responsible Party

FangYi

Chief Physician and Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Fang, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Site Status: ACTIVE_NOT_RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Site Status: ACTIVE_NOT_RECRUITING

Countries

China

Central Contacts

Zheng Qu, MD

Role: CONTACT

quzheng1237@gmail.com

+8615010998669

Facility Contacts

Zheng Qu, MD

Role: primary

quzheng1237@gmail.com

+8615010998669

Other Identifiers

245194799

Identifier Type: -

Identifier Source: org_study_id