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

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: 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
• Treatments: Tegafur

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.