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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
yanfei Liu, Fudan University
ClinicalTrials.gov Identifier:
NCT01526499
First received: January 29, 2012
Last updated: February 5, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarker serum VEGF level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Relationship of serum VEGF level and efficacy

  • Biomarker immuno-marker [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy

  • Efficacy Overall Response Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Overall Response Rate

  • Efficacy Overall Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Overall Survival, OS

  • Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Safety(NCI CTCAE v4.0)

  • genetic polymorphisms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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
Docetaxel
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01526499

Contacts
Contact: Leiping Wang, MD +862164175590 leipingwang@163.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Leiping Wang, MD    +862164175590 ext 8908    leipingwang@163.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Zhonghua Wang, MD Fudan University
  More Information

No publications provided

Responsible Party: yanfei Liu, principal investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01526499     History of Changes
Other Study ID Numbers: TCvsT
Study First Received: January 29, 2012
Last Updated: February 5, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Metronomic cyclophosphamide
metastatic breast cancer
first line
docetaxel

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

ClinicalTrials.gov processed this record on August 28, 2014