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

NCT07010939 | Recruiting DMC

• 1 other identifier: 245194799
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Breast Neoplasms; Treatment-Related Toxicities; Quality of Life; Patient-Reported Outcomes; Prospective Study

Outcome Measures

Primary Outcomes (1)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  Quality of life will be measured using the EORTC QLQ-C30, a 30-item questionnaire that includes a global health status/QoL scale, five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, nausea/vomiting, pain), and several single-item symptom measures. Score range: Each scale is transformed to a 0-100 scale. Interpretation: For functional and global health status scales, higher scores indicate better functioning or quality of life. For symptom scales, higher scores indicate worse symptom burden. Changes from baseline will be analyzed across follow-up timepoints.

  Baseline, 1week, 1 month, 3 months, 6 months, 12 months, annually up to 5 years

Secondary Outcomes (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)

  Baseline, 1 week, 1 month, 3 months, 6 months, 12 months, then annually up to 5 years

Study Arms (1)

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.

Procedure: blood sampling

Interventions

blood sampling 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.

Early-Stage Breast Cancer Patients Receiving Local Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from multiple hospitals across China. The study is coordinated by the Cancer Hospital, Chinese Academy of Medical Sciences (CAMS), and includes collaborating sites such as Shanxi Cancer Hospital and the CAMS Cancer Hospital Shenzhen branch. Additional centers from both northern and southern regions of China will be added as the study expands. The study population includes women diagnosed with stage I-III breast cancer who are receiving local therapy in real-world clinical settings across diverse geographic areas.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FangYi: lead

Study Sites (3)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518116, China

ACTIVE NOT RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood: Plasma and peripheral blood mononuclear cells (PBMCs) will be collected using EDTA anticoagulant tubes. Plasma will be processed and stored at -80°C for future biomarker and multi-omics analyses. PBMCs will be isolated and cryopreserved in liquid nitrogen. Tumor tissue: Formalin-fixed and/or fresh-frozen samples of tumor tissue will be collected during breast cancer surgery. Adjacent normal breast tissue: When available, paired peritumoral normal tissue samples will also be collected during surgery. All samples will be stored in a centralized biobank under standard quality-controlled conditions for future translational research related to treatment-related toxicities and recovery in breast cancer patients.

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yi Fang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Qu, MD

CONTACT

+8615010998669; quzheng1237@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician and Professor

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We will consider access to study data upon written detailed request sent to us, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from the study for personal access, and data will only be transferred after signing of a data access agreement.

Locations

CN (3)