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

Capital Medical University200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Breast Neoplasms Neoplasm Metastasis

Interventions

Cyclophosphamide 50mgDRUG

Letrozole 2.5 mgDRUG

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, China

Outcomes

Primary Outcomes

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).

Time frame: up to approximately 2 years

Secondary Outcomes

Safety of each treatment regimen for the subjects

Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .

Time frame: up to approximately 2 years

Evaluate the quality of life for the subjects in the each treatment regimen

Subjects complete questionnaire in every 8 weeks.

Time frame: up to approximately 2 years

Compare disease control rate for the subjects

Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.

Time frame: up to approximately 2 years

Data from ClinicalTrials.gov

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