Clinical trial NCT03543072: A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients
Official title: A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy

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.

Detailed description: 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. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects, especially increasing the risk of hyperlipidemia, cardiovascular disease and osteoporosis in postmenopausal women. It is a multicenter prospective observational study. The postmenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. 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 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 this population.In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Eligibility criteria: Inclusion Criteria:

1. Informed consent form has been signed.
2. Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.
3. 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.
4. Plan for adjuvant or neoadjuvant chemotherapy.

Exclusion Criteria:

1. Those who have already received adjuvant or neoadjuvant chemotherapy.
2. Those who have chemotherapy contraindications.
3. Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.

Primary outcomes:
measure: The rate of osteoporosis
timeFrame: 5 years
Secondary outcomes:
measure: The risk of osteoporotic fracture
timeFrame: 5 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Shusen Wang
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Shusen Wang
role: PRINCIPAL_INVESTIGATOR
References: