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

Primary Purpose

Breast Neoplasms, Neoplasm Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cyclophosphamide 50mg
Letrozole 2.5 mg
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Cyclophosphamide alone

Cyclophosphamide plus letrozole for resistant patients

Cyclophosphamide plus letrozole for treat-naive patients

letrozole alone

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Safety of each treatment regimen for the subjects
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
Subjects complete questionnaire in every 8 weeks.
Compare disease control rate for the subjects
Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.

Full Information

First Posted
October 13, 2015
Last Updated
January 2, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02583828
Brief Title
Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cyclophosphamide plus letrozole for resistant patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Cyclophosphamide plus letrozole for treat-naive patients
Arm Type
Experimental
Arm Description
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.
Arm Title
letrozole alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide 50mg
Intervention Type
Drug
Intervention Name(s)
Letrozole 2.5 mg
Primary Outcome Measure Information:
Title
Progression free survival(PFS) of the subjects
Description
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 Outcome Measure Information:
Title
Safety of each treatment regimen for the subjects
Description
Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .
Time Frame
up to approximately 2 years
Title
Evaluate the quality of life for the subjects in the each treatment regimen
Description
Subjects complete questionnaire in every 8 weeks.
Time Frame
up to approximately 2 years
Title
Compare disease control rate for the subjects
Description
Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.
Time Frame
up to approximately 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ren, MD,PhD
Phone
6810-63926317
Email
renjun9688@yahoo.com
Facility Information:
Facility Name
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD, PhD
Phone
86-10-63926317
Email
renjun9688@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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