Metastatic Breast CancerPhase 3NCT01655992
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
A Phase 3 study testing capecitabine and S1 generic in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- capecitabine and S1 generic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Oct 2017
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer
- Pretreated metastatic breast cancer not more than 2 lines chemotherapy
- Have not been previously treated with capecitabine,oral fluracil
- ECOG performance status of ≤ 1
- Be female and ≥ 18 and ≤ 75 years of age
- Have at least one target lesion according to the RECIST criteria 1.1
Who cannot join
- Pregnant or lactating women
- ECOG ≥ 2
- Have been treated with capecitabine
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- Abnormal laboratory values: hemoglobin < 10.0 g/dl, absolute neutrophil count < 1.5×10^9/L, platelet count < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
- Serious uncontrolled intercurrent infection
- Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
Read the detailed description
Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- capecitabine, S1 generic
- Keywords
- capecitabine, Tegafur，Gimeracil and Oteracil Potassium Capsules
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda
2500mg／m2／day divided into twice two weeks on one week off
S1 genericDrug
Also called Tegafur，Gimeracil and Oteracil Potassium Capsules
40mg／m2 bid four weeks on two weeks off
| Study group | Role | What they receive |
|---|---|---|
| S1 generic | Experimental | 40mg／m2 bid four weeks on two weeks off Receives: Drug: S1 generic |
| capecitabine | Active comparator | 2500mg／m2／day divided into twice two weeks on one week off Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 6 months
Secondary outcomes (2)
response rate
Measured: 1.5 months
overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: The sponsor decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xi-chun Hu, MD,PhD, Principal investigator, Fudan Univeristy Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655992
- Sponsor's protocol ID
- Fudan BR2012-09 CBCSG011
- Status last verified
- Jan 2018
- First submitted
- 27 Jul 2012
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT01655992
- Acronym / sponsor ID
- Fudan BR2012-09 CBCSG011
- Conditions
- Metastatic Breast Cancer
- Keywords
- capecitabine, Tegafur，Gimeracil and Oteracil Potassium Capsules
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to stop the study.
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Aug 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.
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
Detailed description
Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With 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 |
|---|---|---|
| S1 generic | Experimental | Drug: S1 generic40mg／m2 bid four weeks on two weeks off |
| capecitabine | Active comparator | Drug: capecitabine2500mg／m2／day divided into twice two weeks on one week off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed breast cancer
- Pretreated metastatic breast cancer not more than 2 lines chemotherapy
- Have not been previously treated with capecitabine,oral fluracil
- ECOG performance status of ≤ 1
- Be female and ≥ 18 and ≤ 75 years of age
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- ECOG ≥ 2
- Have been treated with capecitabine
- Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
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 |
|---|---|---|
| capecitabineAlso: Xeloda2500mg／m2／day divided into twice two weeks on one week off | Drug | capecitabine |
| S1 genericAlso: Tegafur，Gimeracil and Oteracil Potassium Capsules40mg／m2 bid four weeks on two weeks off | Drug | S1 generic |
Primary outcome
progression free survival
Time frame: 6 months
2 secondary outcomes
response rate
Time frame: 1.5 months
overall survival
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The sponsor decided to stop the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Xi-chun Hu, MD,PhD principal investigator
Fudan Univeristy Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capecitabine and S1 generic in people with Metastatic 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 6 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: stopped early, as of the sponsor's last update on 23 Jan 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: The sponsor decided to stop the study.). Results are not available in the source record.
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?
progression free survival (time frame: 6 months). 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 23 Jan 2018.