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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01526499
• Other study ID #: TCvsT
• Status: Recruiting
• Phase: Phase 2
• First received: January 29, 2012
• Last updated: February 5, 2012
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: Leiping Wang, MD
• Phone: +862164175590
• Email: leipingwang[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel and Cyclophosphamide (TC)
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
• Docetaxel (T)
Docetaxel 75mg/m2 IVGTT D1;every 21days

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		6 weeks	No
Secondary	Biomarker serum VEGF level	Relationship of serum VEGF level and efficacy	6 weeks	No
Secondary	Biomarker immuno-marker	Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy	6 weeks	No
Secondary	Efficacy Overall Response Rate	Overall Response Rate	6 weeks	No
Secondary	Efficacy Overall Survival	Overall Survival, OS	6 weeks	No
Secondary	Safety	Safety(NCI CTCAE v4.0)	6 weeks	Yes
Secondary	genetic polymorphisms	To evaluate the relationship of genetic polymorphisms and efficacy.	6 weeks	No