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

February 5, 2012 updated by: yanfei Liu, Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TC
Docetaxel plus Cyclophosphamide
Drug: Docetaxel and Cyclophosphamide (TC)
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
Active Comparator: T
Docetaxel
Drug: Docetaxel (T)
Docetaxel 75mg/m2 IVGTT D1;every 21days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhonghua Wang, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

January 29, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 5, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCvsT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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