Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer
NCT ID: NCT01526512
Last Updated: 2012-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
NCT01526499
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
NCT00589901
Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
NCT01924078
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
NCT07019337
Capecitabine in Low Risk Triple Negative Breast Cancer
NCT06787339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
metroCX
metroCX Cyclophosphamide 50mg PO d1-28; Capecitabine 1500mg PO d1-28; every 28days
metroCX
cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
metroCX
cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
yanfei Liu
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhonghua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
metroCX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.