Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer

The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: metroCX

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Center
      • Contact: Leiping Wang, MD; Phone Number: 8908 +862164175590; Email: leipingwang@163.com
    • Shanghai, Shanghai, China, 200032
      • Active, not recruiting
      • Fudan University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker	Relationship of serum VEGF level and efficacy	6 weeks
Biomarker	Relationship of immuno-marker(CD3,CD4,CD8,etc) and efficacy	6weeks
Biomarker	Relationship of genetics(genetic polymorphisms) and efficacy	1 time
Efficacy	Overall Response rate	6 weeks
Efficacy	Overall Survival	6 weeks
Safety	Safety（NCI CTCAE v4.0）	3 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Zhonghua Wang, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 29, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: February 5, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: HER2-negative breast cancer; Metronomic capecitabine; Metronomic cyclophosphamide
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: metroCX