Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel and Cyclophosphamide (TC) Type: Drug
Name: Docetaxel (T) Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
Detailed Description
Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Females with age between 18 and 70 years old

2. ECOG performance between 0-1

3. Life expectancy more than 3 months

4. Histological proven unresectable recurrent or advanced breast cancer

5. No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).

6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)

7. No anticancer therapy within 4 weeks

8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney

9. Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)

2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study

3. Treatment with an investigational product within 4 weeks before the first treatment

4. Symptomatic central nervous system metastases

5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions

7. Uncontrolled serious infection

8. Patients with bad compliance
Location
Fudan University Cancer Hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: Leiping Wang, MD - +862164175590 - leipingwang@163.com
Start Date
December 2011
Completion Date
July 2013
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page