Docetaxel With or Without Metronomic Cyclophosphamide as... | NCT01526499

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

NCT01526499

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Feb 7, 2012Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Docetaxel and Cyclophosphamide (TC)
Docetaxel (T)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2013Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Jan 29, 2012

First Submission Date that Met QC Criteria

Feb 3, 2012

First Posted Date

Feb 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2012

Last Update Posted Date

Feb 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TC	Experimental	Docetaxel plus Cyclophosphamide	Drug: Docetaxel and Cyclophosphamide (TC)
T	Active Comparator	Docetaxel	Drug: Docetaxel (T)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel and Cyclophosphamide (TC)	Drug	Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days	TC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Biomarker serum VEGF level	Relationship of serum VEGF level and efficacy	6 weeks
Biomarker immuno-marker	Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females with age between 18 and 70 years old
ECOG performance between 0-1
Life expectancy more than 3 months
Histological proven unresectable recurrent or advanced breast cancer
No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).
At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
No anticancer therapy within 4 weeks
Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

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)
Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
Treatment with an investigational product within 4 weeks before the first treatment
Symptomatic central nervous system metastases
Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
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
Uncontrolled serious infection
Patients with bad compliance

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic