Breast CancerPhase 2NCT01526499
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
A Phase 2 study testing Docetaxel and Cyclophosphamide (TC) and Docetaxel (T) in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel and Cyclophosphamide (TC) and Docetaxel (T)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Leiping Wang, MD, +862164175590 ext. 8908, leipingwang@163.com
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel and Cyclophosphamide (TC), Docetaxel (T)
- Keywords
- Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and Cyclophosphamide (TC)Drug
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
Docetaxel (T)Drug
Docetaxel 75mg/m2 IVGTT D1;every 21days
| Study group | Role | What they receive |
|---|---|---|
| TC | Experimental | Docetaxel plus Cyclophosphamide Receives: Drug: Docetaxel and Cyclophosphamide (TC) |
| T | Active comparator | Docetaxel Receives: Drug: Docetaxel (T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 6 weeks
Secondary outcomes (6)
Biomarker serum VEGF level
Relationship of serum VEGF level and efficacy
Measured: 6 weeks
Biomarker immuno-marker
Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
Measured: 6 weeks
Efficacy Overall Response Rate
Overall Response Rate
Measured: 6 weeks
Efficacy Overall Survival
Overall Survival, OS
Measured: 6 weeks
Safety
Safety（NCI CTCAE v4.0）
Measured: 6 weeks
genetic polymorphisms
To evaluate the relationship of genetic polymorphisms and efficacy.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yanfei Liu, Fudan University
- Investigators
- Zhonghua Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526499
- Sponsor's protocol ID
- TCvsT
- Status last verified
- Feb 2012
- First submitted
- 29 Jan 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01526499
- Acronym / sponsor ID
- TCvsT
- Conditions
- Breast Cancer
- Keywords
- Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TC | Experimental | Drug: Docetaxel and Cyclophosphamide (TC)Docetaxel plus Cyclophosphamide |
| T | Active comparator | Drug: Docetaxel (T)Docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel and Cyclophosphamide (TC)Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days | Drug | TC |
| Docetaxel (T)Docetaxel 75mg/m2 IVGTT D1;every 21days | Drug | T |
Primary outcome
Progression Free Survival
Time frame: 6 weeks
6 secondary outcomes
Biomarker serum VEGF level
Time frame: 6 weeks
Biomarker immuno-marker
Time frame: 6 weeks
Efficacy Overall Response Rate
Time frame: 6 weeks
Efficacy Overall Survival
Time frame: 6 weeks
Safety
Time frame: 6 weeks
genetic polymorphisms
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhonghua Wang, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Cyclophosphamide (TC) and Docetaxel (T) in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leiping Wang, MD (+862164175590, leipingwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.