Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in 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:
NCT01526499
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 metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Docetaxel and Cyclophosphamide (TC) Drug: Docetaxel (T) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Biomarker serum VEGF level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Relationship of serum VEGF level and efficacy
- Biomarker immuno-marker [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
- Efficacy Overall Response Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Overall Response Rate
- Efficacy Overall Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Overall Survival, OS
- Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Safety(NCI CTCAE v4.0)
- genetic polymorphisms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]To evaluate the relationship of genetic polymorphisms and efficacy.
| Estimated Enrollment: | 60 |
| 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: TC
Docetaxel plus Cyclophosphamide
|
Drug: Docetaxel and Cyclophosphamide (TC)
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
|
|
Active Comparator: T
Docetaxel
|
Drug: Docetaxel (T)
Docetaxel 75mg/m2 IVGTT D1;every 21days
|
Detailed Description:
Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Females with age between 18 and 70 years old
- ECOG performance between 0-1
- Life expectancy more than 3 months
- Histological proven unresectable recurrent or advanced breast cancer
- No previous chemotherapy 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526499
Contacts
| Contact: Leiping Wang, MD | +862164175590 | leipingwang@163.com |
Locations
| China, Shanghai | |
| Fudan University Cancer Hospital | 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: | NCT01526499 History of Changes |
| Other Study ID Numbers: | TCvsT |
| Study First Received: | January 29, 2012 |
| Last Updated: | February 5, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Metronomic cyclophosphamide metastatic breast cancer first line docetaxel |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel 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 |
ClinicalTrials.gov processed this record on May 21, 2013