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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01526512
• Other study ID #: metroCX
• Status: Recruiting
• Phase: Phase 2
• First received: January 29, 2012
• Last updated: February 5, 2012
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: Leiping Wang, MD
• Phone: +862164175590
• Email: leipingwang[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• metroCX
cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		6 weeks	No
Secondary	Biomarker	Relationship of serum VEGF level and efficacy	6 weeks	Yes
Secondary	Biomarker	Relationship of immuno-marker(CD3,CD4,CD8,etc) and efficacy	6weeks	No
Secondary	Biomarker	Relationship of genetics(genetic polymorphisms) and efficacy	1 time	No
Secondary	Efficacy	Overall Response rate	6 weeks	No
Secondary	Efficacy	Overall Survival	6 weeks	No
Secondary	Safety	Safety(NCI CTCAE v4.0)	3 weeks	Yes