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Completed

NCT Number: NCT02583828

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide 50mg

Drug

letrozole 2.5 mg

Drug

Primary outcomes

  1. Progression free survival(PFS) of the subjects

    Time frame: 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 outcomes

  1. Safety of each treatment regimen for the subjects

    Time frame: up to approximately 2 years

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

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

    Time frame: up to approximately 2 years

    Subjects complete questionnaire in every 8 weeks.

  3. Compare disease control rate for the subjects

    Time frame: up to approximately 2 years

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

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Oct 22, 2015
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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