This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by yanfei Liu, Fudan University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
yanfei Liu, Fudan University Identifier:
First received: January 29, 2012
Last updated: February 5, 2012
Last verified: February 2012
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 Intervention Phase
Breast Cancer Drug: Docetaxel and Cyclophosphamide (TC) Drug: Docetaxel (T) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by yanfei Liu, Fudan University:

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

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

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

  • Efficacy Overall Response Rate [ Time Frame: 6 weeks ]
    Overall Response Rate

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

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

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

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: yanfei Liu, principal investigator, Fudan University Identifier: NCT01526499     History of Changes
Other Study ID Numbers: TCvsT
Study First Received: January 29, 2012
Last Updated: February 5, 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 processed this record on September 21, 2017