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

Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative 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 low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Condition Intervention Phase
Breast Cancer Drug: metroCX Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group 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:
  • PFS [ Time Frame: 6 weeks ]

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

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

  • Biomarker [ Time Frame: 1 time ]
    Relationship of genetics(genetic polymorphisms) and efficacy

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

  • Efficacy [ Time Frame: 6 weeks ]
    Overall Survival

  • Safety [ Time Frame: 3 weeks ]
    Safety(NCI CTCAE v4.0)

Estimated Enrollment: 72
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: metroCX
metroCX Cyclophosphamide 50mg PO d1-28; Capecitabine 1500mg PO d1-28; every 28days
Drug: metroCX
cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days

Detailed Description:
Metronomic chemotherapy has been considered as an effective strategy in metastatic breast cancer. This trial is designed to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Females with age between 18 and 80 years old
  2. ECOG performance between 0-3
  3. Life expectancy more than 3 months
  4. Histological proven unresectable recurrent or advanced HER2-negative breast cancer
  5. At least one previous therapy regimen (including endocrine therapy) 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
  10. Previous capecitabine is permitted, however, it should be completed at least 6 months.

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
  9. Patients lack of Dihydropyrimidine Dehydrogenase(DPD)
  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: NCT01526512

Contact: Leiping Wang, MD +862164175590

China, Shanghai
Fudan University Cancer Center Active, not recruiting
Shanghai, Shanghai, China, 200032
Fudan University Cancer Center 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: NCT01526512     History of Changes
Other Study ID Numbers: metroCX
Study First Received: January 29, 2012
Last Updated: February 5, 2012

Keywords provided by yanfei Liu, Fudan University:
Metronomic cyclophosphamide
Metronomic capecitabine
HER2-negative breast cancer

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
Antimetabolites, Antineoplastic
Antimetabolites processed this record on August 22, 2017