Breast NeoplasmsPERSEVERENCT07010939
A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer Patients
An observational study of Breast Neoplasms and Quality of Life (QOL), run by FangYi at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Quality of Life (QOL), Toxicities
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 3 sitesChina
- Study dates
- 7 Apr 2025to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Zheng Qu, MD, +8615010998669, quzheng1237@gmail.com
Yi Fang, MD
- Active, not recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518116
- Active, not recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
About this study
Official title: A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)
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.
Read more
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.
Read the 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
- Being tested
- blood sampling
- Keywords
- Breast Neoplasms, Treatment-Related Toxicities, Quality of Life, Patient-Reported Outcomes, Prospective Study
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Cancer-related fatigue will be assessed using the EORTC QLQ-FA12, a 12-item validated module measuring fatigue in three dimensions: physical, emotional, and cognitive.
Score range: Each dimension is linearly transformed to a score from 0 to 100.
Interpretation: Higher scores indicate greater fatigue (worse outcome). This outcome will track changes in fatigue over time and examine associations with clinical, biological, and psychosocial factors.
Measured: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months, then annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start7 Apr 2025
- Primary completion1 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- FangYi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FangYi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yi Fang, MD, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010939
- Sponsor's protocol ID
- 245194799
- Acronym
- PERSEVERE
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PERSEVERE will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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.
PubMed 41922058
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)
- ClinicalTrials.gov ID
- NCT07010939
- Acronym / sponsor ID
- PERSEVERE / 245194799
- Conditions
- Breast Neoplasms, Quality of Life (QOL), Toxicities, Breast Diseases
- Keywords
- Breast Neoplasms, Treatment-Related Toxicities, Quality of Life, Patient-Reported Outcomes, Prospective Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- FangYiUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-Stage Breast Cancer Patients Receiving Local Therapy | – | Procedure: blood samplingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAt 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. | Procedure or surgery | Early-Stage Breast Cancer Patients Receiving Local Therapy |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 41922058Qu 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.
- Individual participant dataSharing planned: Yes. PERSEVERE will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Fang, MD 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Quality of Life (QOL), run by FangYi at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Qu, MD (+8615010998669, quzheng1237@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07010939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.