Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life (QOL) | — | UNRESOLVED | — |
| Toxicities | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Early-Stage Breast Cancer Patients Receiving Local Therapy
- description
- 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.
- interventionNames
- Procedure: blood sampling
Primary outcomes (1)
- measure
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
- timeFrame
- Baseline, 1week, 1 month, 3 months, 6 months, 12 months, annually up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDQu 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