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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

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Advanced, Metastatic, Breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

4. Oversight

Data Monitoring Committee

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

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

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

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

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

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

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

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

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

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

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Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer

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