Clinical trial

LET+CTX

Name

LET+CTX

Description

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

Trial arms

Trial start

2015-06-01

Estimated PCD

2020-12-01

Trial end

2021-12-01

Status

Completed

Treatment

Cyclophosphamide 50mg

Arms:

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

Letrozole 2.5 mg

Arms:

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

Size

200

Primary endpoint

Progression free survival(PFS) of the subjects

up to approximately 2 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

Updated at

2024-02-07

1 organization

2 products

2 indications

Organization

Capital Medical University

Product

Indication

Indication

Product