A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients

Sun Yat-sen University

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: Bisphosphonates

Study type: Observational

Funder types: Other

Identifiers

NCT03543072

SCBCG-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

exposure group

Description:

exposed to some factors

Treatment:

Drug: Bisphosphonates

control group

Description:

not exposed to some factors