Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients

Breast Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583828
• Other study ID #: LET+CTX
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2021

Study information

• Verified date: February 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;

• Elderly women (age = 65years)

• Failure or relapse from standard chemotherapy or unfit for chemotherapy

• Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

• Adequate bone marrow, liver and renal function;

• Estimated life expectancy of at least 3 months.

Exclusion Criteria:

• Serious or uncontrolled concurrent medical illness

• Uncontrolled primary and metastatic brain tumor

• History of second primary malignancies

• Having been enrolled in other clinical trials within a month

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Cyclophosphamide 50mg

• Letrozole 2.5 mg

Locations

Country	Name	City	State
China	Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival(PFS) of the subjects	Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects).	up to approximately 2 years
Secondary	Safety of each treatment regimen for the subjects	Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .	up to approximately 2 years
Secondary	Evaluate the quality of life for the subjects in the each treatment regimen	Subjects complete questionnaire in every 8 weeks.	up to approximately 2 years
Secondary	Compare disease control rate for the subjects	Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.	up to approximately 2 years