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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526499
Recruitment Status : Unknown
Verified February 2012 by yanfei Liu, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 6, 2012
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
yanfei Liu, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel and Cyclophosphamide (TC) Drug: Docetaxel (T) Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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
Drug: Docetaxel (T)
Docetaxel 75mg/m2 IVGTT D1;every 21days

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Biomarker serum VEGF level [ Time Frame: 6 weeks ]
    Relationship of serum VEGF level and efficacy

  2. Biomarker immuno-marker [ Time Frame: 6 weeks ]
    Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy

  3. Efficacy Overall Response Rate [ Time Frame: 6 weeks ]
    Overall Response Rate

  4. Efficacy Overall Survival [ Time Frame: 6 weeks ]
    Overall Survival, OS

  5. Safety [ Time Frame: 6 weeks ]
    Safety(NCI CTCAE v4.0)

  6. genetic polymorphisms [ Time Frame: 6 weeks ]
    To evaluate the relationship of genetic polymorphisms and efficacy.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526499

Contact: Leiping Wang, MD +862164175590

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Leiping Wang, MD    +862164175590 ext 8908   
Sponsors and Collaborators
Fudan University
Principal Investigator: Zhonghua Wang, MD Fudan University

Responsible Party: yanfei Liu, principal investigator, Fudan University Identifier: NCT01526499     History of Changes
Other Study ID Numbers: TCvsT
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by yanfei Liu, Fudan University:
Metronomic cyclophosphamide
metastatic breast cancer
first line

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators