Overview

Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer

Status:
Unknown status
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Cyclophosphamide
Docetaxel
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