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

NCT03543059 | Unknown

• 1 other identifier: SCBCG-021
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcome

  The number of patients reporting pregnancy and attempting pregnancy

  5 years

Secondary Outcomes (1)

• Rate of ovarian failure

  2 years

Study Arms (2)

exposure group

exposed to some factors

Drug: GnRH analogue

control group

not exposed to some factors

Interventions

GnRH analogue DRUG

gonadotrophin releasing hormone analogue

exposure group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Premenopausal 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.
• Plan for adjuvant or neoadjuvant chemotherapy

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Shusen Wang

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Shusen Wang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shusen Wang

CONTACT

+86-13926168469; wangshs@sysucc.org.cn

Kuikui Jiang

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

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 1, 2018

Record last verified: 2018-05

Locations

CN (1)