Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer
This study is currently recruiting participants.
Verified February 2012 by Fudan University
Sponsor:
Fudan University
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
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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:
- Females with age between 18 and 80 years old
- ECOG performance between 0-3
- Life expectancy more than 3 months
- Histological proven unresectable recurrent or advanced HER2-negative breast cancer
- 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).
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
- No anticancer therapy within 4 weeks
- Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
- Provision of written informed consent prior to any study specific procedures
- Previous capecitabine is permitted, however, it should be completed at least 6 months.
Exclusion Criteria:
- 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)
- Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
- Treatment with an investigational product within 4 weeks before the first treatment
- Symptomatic central nervous system metastases
- Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
- 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
- Uncontrolled serious infection
- Patients with bad compliance
- Patients lack of Dihydropyrimidine Dehydrogenase(DPD)
Contacts and Locations
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 May 21, 2013