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

Not Applicable

Completed

• Conditions: Neoplasm Metastasis; Breast Neoplasms
• Interventions: Drug: Letrozole 2.5 mg; Drug: Cyclophosphamide 50mg

• Registration Number: NCT02583828
• Lead Sponsor: Capital Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2020-12
• Study Completion: 2021-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letrozole alone	Letrozole 2.5 mg	Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily.
Cyclophosphamide plus letrozole for resistant patients	Cyclophosphamide 50mg	Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
Cyclophosphamide plus letrozole for resistant patients	Letrozole 2.5 mg	Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
Cyclophosphamide plus letrozole for treat-naive patients	Cyclophosphamide 50mg	Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
Cyclophosphamide plus letrozole for treat-naive patients	Letrozole 2.5 mg	Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
Cyclophosphamide alone	Cyclophosphamide 50mg	Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily.

Primary Outcome Measures

Name	Time	Method
Progression free survival(PFS) of the subjects	up to approximately 2 years	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate the quality of life for the subjects in the each treatment regimen	up to approximately 2 years	Subjects complete questionnaire in every 8 weeks.
Safety of each treatment regimen for the subjects	up to approximately 2 years	Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .
Compare disease control rate for the subjects	up to approximately 2 years	Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.

Trial Locations

Locations (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital; 🇨🇳 Beijing, China