A Trial Comparing S1 Generic With Capecitabine in Metasta... | NCT01655992

Studies
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

NCT01655992

Sponsor

Fudan University

Status

Terminated

Last Update Posted

Jan 23, 2018Actual

Enrollment

386Estimated

Phase

Phase 3

Conditions

Metastatic Breast Cancer

Interventions

capecitabine
S1 generic

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsor decided to stop the study.

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Jul 27, 2012

First Submission Date that Met QC Criteria

Aug 1, 2012

First Posted Date

Aug 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2018

Last Update Posted Date

Jan 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

386Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S1 generic	Experimental	40mg／m2 bid four weeks on two weeks off	Drug: S1 generic
capecitabine	Active Comparator	2500mg／m2／day divided into twice two weeks on one week off	Drug: capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
capecitabine	Drug	2500mg／m2／day divided into twice two weeks on one week off	capecitabine

Measure	Description	Time Frame
progression free survival		6 months

Measure	Description	Time Frame
response rate		1.5 months
overall survival		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xi-chun Hu, MD,PhD	Fudan Univeristy Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital		Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine
C489337	potassium oxonate

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided