Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
NCT ID: NCT01492543
Last Updated: 2013-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2011-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aiyi®
Tegafur Gimeracil Oteracil Potassium Capsule
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.,
Interventions
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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.,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Beijing Chao Yang Hospital
OTHER
Chinese PLA General Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Hebei Tumor Hospital
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Binghe Xu
Deputy Director of Department of Medical Oncology
Principal Investigators
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Binghe Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Beijing Chao-yang Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-BC-014
Identifier Type: -
Identifier Source: org_study_id
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