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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Bisphosphonates

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Shusen Wang; Phone Number: +86-13926168469; Email: wangshs@sysucc.org.cn
• Study Contact Backup: Name: Kuikui Jiang; Phone Number: +86-15210589011; Email: jiangkk@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China
      • Shusen Wang
      • Contact: Shusen Wang, doctor; Phone Number: +86-13926168469; Email: wangshs@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exposure group; exposed to some factors	Drug: Bisphosphonates; a class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases
control group; not exposed to some factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of osteoporosis	According to the result of bone mineral density	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The risk of osteoporotic fracture	Calculate the risk of osteoporotic fracture with the WHO Fracture Risk Assessment Tool (FRAX® ) (http://www.shef.ac.uk/FRAX/)	5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2018
• Primary Completion (ANTICIPATED): June 15, 2021
• Study Completion (ANTICIPATED): June 15, 2023

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Bone Density Conservation Agents; Diphosphonates
• Other Study ID Numbers: SCBCG-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No