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

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01526512
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 36
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: metroCX	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2013
• Anticipated Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. PFS [6 weeks]

Secondary Outcome Measures

1. Biomarker [6 weeks]

   Relationship of serum VEGF level and efficacy

2. Biomarker [6weeks]

   Relationship of immuno-marker(CD3,CD4,CD8,etc) and efficacy

3. Biomarker [1 time]

   Relationship of genetics(genetic polymorphisms) and efficacy

4. Efficacy [6 weeks]

   Overall Response rate

5. Efficacy [6 weeks]

   Overall Survival

6. Safety [3 weeks]

   Safety（NCI CTCAE v4.0）

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Center	Shanghai	Shanghai	China	200032
2	Fudan University Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Zhonghua Wang, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yanfei Liu, Principal investigator, Fudan University
• ClinicalTrials.gov Identifier: NCT01526512
• Other Study ID Numbers: metroCX
• First Posted: Feb 6, 2012
• Last Update Posted: Feb 7, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by yanfei Liu, Principal investigator, Fudan University: Metronomic cyclophosphamide; Metronomic capecitabine; HER2-negative breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 7, 2012