Breast CancerPhase 2NCT00629148
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
A Phase 2 study testing Vinorelbine and Capecitabine in people with Breast Cancer and Metastasis, Neoplasm, run by Fudan University at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Metastasis, Neoplasm
- What is being tested?
- Vinorelbine and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Dec 2010
- 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
- Signed informed consent.
- Female, ≥ 18 and ≤ 70 years.
- Histologically confirmed invasive breast cancer.
- Metastatic breast cancer.
- ECOG Performance Status of 0 to 2.
- Life expectancy of more than 3 months.
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- Subject must have adequate organ function.
- Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 80×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN.
- Negative serum pregnancy test for women with childbearing potential.
- Good conditions for infusion and willing to have phlebotomy throughout whole study.
- Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
- Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Who cannot join
- Pregnant or lactating females
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- Active or uncontrolled infection
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- Concomitant with brain metastases
- Have received chemotherapy after metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
Read the detailed description
The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.
- Conditions
- Breast Cancer, Metastasis, Neoplasm
- Being tested
- Vinorelbine and Capecitabine
- Keywords
- metastasis, chemotherapy, breast cancer, Vinorelbine, Capecitabine, sequential chemotherapy, TTF
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine and CapecitabineDrug
Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
Vinorelbine and CapecitabineDrug
Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
| Study group | Role | What they receive |
|---|---|---|
| combination chemotherapy | Active comparator | Simultaneous use of Vinorelbine and Capecitabine Receives: Drug: Vinorelbine and Capecitabine |
| sequential chemotherapy | Experimental | Sequential use of Vinorelbine and Capecitabine Receives: Drug: Vinorelbine and Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.
Measured: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
Secondary outcomes (2)
Safety, QOL(quality of life)
Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.
Measured: Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
TTP(time to progression) and OS (overall survival)
TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.
Measured: TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionDec 2010
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 (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- XiChun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629148
- Sponsor's protocol ID
- 2007SSVC
- Status last verified
- Jun 2011
- First submitted
- 26 Feb 2008
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00629148
- Acronym / sponsor ID
- 2007SSVC
- Conditions
- Breast Cancer, Metastasis, Neoplasm
- Keywords
- metastasis, chemotherapy, breast cancer, Vinorelbine, Capecitabine, sequential chemotherapy, TTF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Mar 2008 (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 primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
Detailed description
The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination chemotherapy | Active comparator | Drug: Vinorelbine and CapecitabineSimultaneous use of Vinorelbine and Capecitabine |
| sequential chemotherapy | Experimental | Drug: Vinorelbine and CapecitabineSequential use of Vinorelbine and Capecitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent.
- Female, ≥ 18 and ≤ 70 years.
- Histologically confirmed invasive breast cancer.
- Metastatic breast cancer.
- ECOG Performance Status of 0 to 2.
Key exclusion criteria (7 listed)
- Pregnant or lactating females
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- Active or uncontrolled infection
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
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 |
|---|---|---|
| Vinorelbine and CapecitabineVinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w | Drug | combination chemotherapy |
| Vinorelbine and CapecitabineVinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w | Drug | sequential chemotherapy |
Primary outcome
PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
Time frame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.
2 secondary outcomes
Safety, QOL(quality of life)
Time frame: Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
TTP(time to progression) and OS (overall survival)
Time frame: TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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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.
XiChun Hu, MD, PhD 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 Vinorelbine and Capecitabine in people with Breast Cancer and Metastasis, Neoplasm, 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 12 inclusion and 7 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: finished, as of the sponsor's last update on 7 Jul 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause) (time frame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.). 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 Jul 2011.