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

Capital Medical University

Status: Completed

Conditions: Neoplasm Metastasis; Breast Neoplasms

Treatments: Drug: Letrozole 2.5 mg; Drug: Cyclophosphamide 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02583828

LET+CTX

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Female

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Cyclophosphamide alone

Active Comparator group

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.

Treatment:

Drug: Cyclophosphamide 50mg

Cyclophosphamide plus letrozole for resistant patients

Experimental group

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.

Treatment:

Drug: Letrozole 2.5 mg

Drug: Cyclophosphamide 50mg

Cyclophosphamide plus letrozole for treat-naive patients

Experimental group

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.

Treatment:

Drug: Letrozole 2.5 mg

Drug: Cyclophosphamide 50mg

letrozole alone

Active Comparator group

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.

Treatment:

Drug: Letrozole 2.5 mg