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

Breast Cancer Clinical Trial

Official title:

A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Premenopausal Women With Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03543059
• Other study ID #: SCBCG-021
• Status: Not yet recruiting
• Start date: June 15, 2018
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2018
• Source: Sun Yat-sen University
• Contact: Shusen Wang
• Phone: +86-13926168469
• Email: wangshs[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is one of the most common malignant tumor in women. About 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in China. It is a multicenter prospective observational study. We will collect basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The aim of the study is to evaluate the effect of chemotherapy on ovarian function and fertility and the protective effect of GnRHa. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Description:

Breast cancer is one of the most common malignant tumor in women, and it occurs at a younger median age in Chinese women than in western white women. About 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in China. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects. It is a multicenter prospective observational study. The premenopausal 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 their basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after chemotherapy. The aim of the study is to evaluate the effect of adjuvant or neoadjuvant chemotherapy on ovarian function and fertility and the protective effect of GnRHa by investigating the menopausal symptoms, pregnancy, menstruation condition, hormone levels, blood lipid, bone density, and the usage of GnRHa in the premenopausal women with breast cancer. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. Plan for adjuvant or neoadjuvant chemotherapy

Exclusion Criteria:

1. 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.

2. Those who have already received adjuvant or neoadjuvant chemotherapy.

3. Those who have chemotherapy contraindications.

4. Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• GnRH analogue
gonadotrophin releasing hormone analogue

Locations

Country	Name	City	State
China	Shusen Wang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcome	The number of patients reporting pregnancy and attempting pregnancy	5 years
Secondary	Rate of ovarian failure	Amenorrhea for 6 months and postmenopausal FSH levels at 24 months (amenorrhea and postmenopausal hormone levels	2 years