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

NCT02583828 | Completed

• 1 other identifier: LET+CTX
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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).

  up to approximately 2 years

Secondary Outcomes (3)

• Safety of each treatment regimen for the subjects

  up to approximately 2 years

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

  up to approximately 2 years

• Compare disease control rate for the subjects

  up to approximately 2 years

Study Arms (4)

Cyclophosphamide alone

ACTIVE COMPARATOR

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.

Drug: Cyclophosphamide 50mg

Cyclophosphamide plus letrozole for resistant patients

EXPERIMENTAL

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.

Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg

Cyclophosphamide plus letrozole for treat-naive patients

EXPERIMENTAL

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.

Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg

letrozole alone

ACTIVE COMPARATOR

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.

Drug: Letrozole 2.5 mg

Interventions

Cyclophosphamide 50mg DRUG

Cyclophosphamide alone; Cyclophosphamide plus letrozole for resistant patients; Cyclophosphamide plus letrozole for treat-naive patients

Letrozole 2.5 mg DRUG

Cyclophosphamide plus letrozole for resistant patients; Cyclophosphamide plus letrozole for treat-naive patients; letrozole alone

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Cyclophosphamide; Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 22, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (1)