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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Binghe Xu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CH-BC-014

NCT ID:

NCT01492543

Start Date:

December 2011

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Advanced
  • Metastatic
  • Breast cancer
  • Breast Neoplasms

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