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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel and Cyclophosphamide (TC); Drug: Docetaxel (T)

• Registration Number: NCT01526499
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-29
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-03
• Last Update Submitted: 2012-02-05
• Study First Posted: 2012-02-06
• Last Update Posted: 2012-02-07
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TC	Docetaxel and Cyclophosphamide (TC)	Docetaxel plus Cyclophosphamide
T	Docetaxel (T)	Docetaxel

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	6 weeks

Secondary Outcome Measures

Name	Time	Method
Biomarker serum VEGF level	6 weeks	Relationship of serum VEGF level and efficacy
Biomarker immuno-marker	6 weeks	Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
Efficacy Overall Response Rate	6 weeks	Overall Response Rate
Efficacy Overall Survival	6 weeks	Overall Survival, OS
Safety	6 weeks	Safety（NCI CTCAE v4.0）
genetic polymorphisms	6 weeks	To evaluate the relationship of genetic polymorphisms and efficacy.

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China