A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients
1 other identifier
observational
2,000
1 country
1
Brief Summary
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedJune 20, 2018
June 1, 2018
3 years
May 21, 2018
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of osteoporosis
According to the result of bone mineral density
5 years
Secondary Outcomes (1)
The risk of osteoporotic fracture
5 years
Study Arms (2)
exposure group
exposed to some factors
control group
not exposed to some factors
Interventions
a class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases
Eligibility Criteria
Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy
You may qualify if:
- Informed consent form has been signed.
- Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.
- Postmenopausal women who are defined by any of the following:
- Previous bilateral oophorectomy;
- Age ≥ 60 years old;
- Age \<60 years old, menopause at least 12 months, and follicle stimulating hormone \[FSH\] and estradiol levels in the postmenopausal range.
- Plan for adjuvant or neoadjuvant chemotherapy.
You may not qualify if:
- Those who have already received adjuvant or neoadjuvant chemotherapy.
- Those who have chemotherapy contraindications.
- Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shusen Wang
Guanzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shusen Wang
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 1, 2018
Study Start
June 15, 2018
Primary Completion
June 15, 2021
Study Completion
June 15, 2023
Last Updated
June 20, 2018
Record last verified: 2018-06