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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01492543
• Other study ID #: CH-BC-014
• Status: Recruiting
• Phase: Phase 2
• First received: December 12, 2011
• Last updated: March 14, 2013
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, MD
• Phone: 86-10-8778-8114
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tegafur Gimeracil Oteracil Potassium Capsule
Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University Cancer Hospital	Beijing	Beijing
China	Hebei Provincial Tumor Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (7)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Beijing Cancer Hospital, Beijing Chao Yang Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Hebei Tumor Hospital, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Up to 2 years	No
Secondary	Clinical response rate	Assessed by RECIST v1.1 criteria.	Every six weeks	No
Secondary	Adverse events		Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years	Yes