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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02583828

Enrollment

200

Registered

2015-10-22

Start date

2015-06-30

Completion date

2021-12-31

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

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.

Interventions

DRUGCyclophosphamide 50mg

DRUGLetrozole 2.5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 .
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.
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026