Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tegafur Gimeracil Oteracil Potassium Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Advanced, Metastatic, Breast cancer
Eligibility Criteria
Inclusion Criteria:
- Age: 18-75 years old female.
- ECOG status: 0-2.
- Life expectancy of ≥ 3 months.
- Histologic or cytologic diagnosis of breast cancer.
- Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
- At least one measurable lesion of >=2 cm (>=1 cm on spiral CT scan)according to RECIST (v1.1).
Adequate organ functions:
- Hematopoietic: Hemoglobin ≥90g/L, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥80×10^9/L.
- Biochemistry: TBil ≤1.5 times upper limit of normal (ULN), AST and ALT ≤2.5× ULN(≤5x ULN if due to liver metastases), Creatinine ≤1.0×ULN and Creatinine clearance >50 ml/min.
- Women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered.
- Ability to take oral medication .
- Signed informed consent.
Exclusion Criteria:
- Pregnancy or lactation or no effective contraception in fertile patients.
- Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
- Less than 4 weeks since prior investigational agents.
- conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
- Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
- CNS or psychiatric disorders.
- Allergic to 5-FU.
- Only with bone metastases and no measurable lesions.
- Clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment.
- Serious peptic ulcer disease or digestive disorders.
- Bone marrow (Hemoglobin <90g/dl, ANC <1.5×10^9/L, Platelet count <75×10^9/L).
- Renal function disorder (Creatinine >1.0×ULN).
- Liver function disorder (TBil >1.5×ULN).
- Uncontrolled brain metastases.
- Noncompliance with the study protocol.
Sites / Locations
- Beijing Chao-yang HospitalRecruiting
- China-Japan Friendship HospitalRecruiting
- Peking University Cancer HospitalRecruiting
- Chinese PLA General HospitalRecruiting
- Hebei Provincial Tumor HospitalRecruiting
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aiyi®
Arm Description
Tegafur Gimeracil Oteracil Potassium Capsule
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Clinical response rate
Assessed by RECIST v1.1 criteria.
Adverse events
Full Information
NCT ID
NCT01492543
First Posted
December 12, 2011
Last Updated
March 14, 2013
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Chinese PLA General Hospital, China-Japan Friendship Hospital, Tianjin Medical University Cancer Institute and Hospital, Hebei Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01492543
Brief Title
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
Official Title
An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Chinese PLA General Hospital, China-Japan Friendship Hospital, Tianjin Medical University Cancer Institute and Hospital, Hebei Tumor Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.
Detailed Description
Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Advanced, Metastatic, Breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aiyi®
Arm Type
Experimental
Arm Description
Tegafur Gimeracil Oteracil Potassium Capsule
Intervention Type
Drug
Intervention Name(s)
Tegafur Gimeracil Oteracil Potassium Capsule
Other Intervention Name(s)
TS-1
Intervention Description
Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Clinical response rate
Description
Assessed by RECIST v1.1 criteria.
Time Frame
Every six weeks
Title
Adverse events
Time Frame
Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-75 years old female.
ECOG status: 0-2.
Life expectancy of ≥ 3 months.
Histologic or cytologic diagnosis of breast cancer.
Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
At least one measurable lesion of >=2 cm (>=1 cm on spiral CT scan)according to RECIST (v1.1).
Adequate organ functions:
Hematopoietic: Hemoglobin ≥90g/L, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥80×10^9/L.
Biochemistry: TBil ≤1.5 times upper limit of normal (ULN), AST and ALT ≤2.5× ULN(≤5x ULN if due to liver metastases), Creatinine ≤1.0×ULN and Creatinine clearance >50 ml/min.
Women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered.
Ability to take oral medication .
Signed informed consent.
Exclusion Criteria:
Pregnancy or lactation or no effective contraception in fertile patients.
Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
Less than 4 weeks since prior investigational agents.
conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
CNS or psychiatric disorders.
Allergic to 5-FU.
Only with bone metastases and no measurable lesions.
Clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment.
Serious peptic ulcer disease or digestive disorders.
Bone marrow (Hemoglobin <90g/dl, ANC <1.5×10^9/L, Platelet count <75×10^9/L).
Renal function disorder (Creatinine >1.0×ULN).
Liver function disorder (TBil >1.5×ULN).
Uncontrolled brain metastases.
Noncompliance with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, MD
Phone
86-10-8778-8114
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, MD, PhD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Yu, MD
Phone
+86-13810292522
Email
xiaoyugw@126.com
First Name & Middle Initial & Last Name & Degree
Hong Dai, MD
First Name & Middle Initial & Last Name & Degree
Dan Yu, MD
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donggui Wan, MD
Phone
+86-13601365686
Email
dongguiwan@263.net
First Name & Middle Initial & Last Name & Degree
Donggui Wan, MD
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Di, MD
Phone
+86-8819-6406
Email
Dilijun2012@gmail.com
First Name & Middle Initial & Last Name & Degree
Lijun Di, MD
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihui Rao, MD
Phone
+86-15110047147
Email
15110047147@163.com
First Name & Middle Initial & Last Name & Degree
Junlan Yang, MD
First Name & Middle Initial & Last Name & Degree
Huihui Rao, MD
Facility Name
Hebei Provincial Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050019
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Wang, MD
Phone
+86-13803343508
Email
125662333@qq.com
First Name & Middle Initial & Last Name & Degree
Wei Liu, MD
First Name & Middle Initial & Last Name & Degree
Long Wang, MD
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Phone
+86-13920458207
Email
tonghang@medmail.com
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
Phone
86-10-8778-8114
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name & Degree
Binghe Xu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
12. IPD Sharing Statement
Learn more about this trial
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
We'll reach out to this number within 24 hrs