Status:
UNKNOWN
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Beijing Chao Yang Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 advanc...
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 effec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01492543
Start Date
December 1 2011
End Date
October 1 2014
Last Update
March 15 2013
Active Locations (7)
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1
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, China, 100020
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100036
4
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853