Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID07010939

A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)

Led by FangYi · Updated on 2025-09-12

3000

Participants Needed

3

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of local treatment on health and daily life in people with early-stage breast cancer in China. The focus is on those with stage I to III invasive breast cancer receiving surgery and other therapies before or after surgery. The study aims to understand both short- and long-term physical, emotional, and social effects of treatment, including tiredness, sleep problems, emotional distress, pain, and changes in heart or lung function, to improve recovery and quality of life. Participants will receive local therapy with curative intent, which may include surgery, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given before or after surgery. This observational study involves no experimental treatment. At the start, participants undergo clinical assessments, including heart and lung tests, lab work, and collection of blood and tissue samples. They also complete questionnaires about symptoms and well-being at multiple time points over five years. During the study, participants will complete surveys about their physical symptoms, emotional health, and quality of life at baseline, one week, one month, three months, six months, one year, and then annually up to five years. Researchers will monitor treatment-related toxicities and quality of life changes through these patient-reported outcomes. The study uses electronic data collection with quality checks to ensure accurate and consistent information for analysis and future research.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • 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
  • Provided written informed consent to join the study
Not Eligible

You will not qualify if you...

  • Have metastatic breast cancer or local recurrence
  • Have already received curative treatment for current breast cancer before joining
  • Currently pregnant or breastfeeding
  • History of another cancer within past 5 years except non-melanoma skin cancer or in-situ cervical cancer
  • Unable to participate due to mental, physical, or legal reasons, such as legal guardianship or imprisonment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline visit

Participants undergo baseline clinical assessments and biospecimen collection to evaluate their health status before local therapy.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants complete electronic questionnaires to monitor treatment-related toxicities and quality of life after local therapy over time.

Questionnaire assessments at postoperative week 1, month 1, month 3, and every 6-12 months thereafter

Trial Site Locations

Total: 3 locations

1

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

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China, 518116

Active, Not Recruiting

3

Shanxi Cancer Hospital

Taiyuan, Shanxi, China, 030013

Active, Not Recruiting

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Research Team

Z

Zheng Qu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

PERSEVERE: longitudinal assessment of quality of life and treatment toxicities in Chinese breast cancer patients - a multicentre cohort study protocol.

Zheng Qu, Haijun Wang, Qi Li...

https://pubmed.ncbi.nlm.nih.gov/41922058