Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative 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:
NCT01526512
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 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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fudan University:

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

Secondary Outcome Measures:
  • Biomarker [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Relationship of serum VEGF level and efficacy

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

  • Biomarker [ Time Frame: 1 time ] [ Designated as safety issue: No ]
    Relationship of genetics(genetic polymorphisms) and efficacy

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

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

  • Safety [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01526512

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

Locations
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    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: NCT01526512     History of Changes
Other Study ID Numbers: metroCX
Study First Received: January 29, 2012
Last Updated: February 5, 2012
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Capecitabine
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
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 29, 2014