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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborators:
Beijing Cancer Hospital
Beijing Chao Yang Hospital
Chinese PLA General Hospital
China-Japan Friendship Hospital
Tianjin Medical University Cancer Institute and Hospital
Hebei Tumor Hospital
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01492543
First received: December 12, 2011
Last updated: March 14, 2013
Last verified: March 2013

December 12, 2011
March 14, 2013
December 2011
April 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01492543 on ClinicalTrials.gov Archive Site
  • Clinical response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
    Assessed by RECIST v1.1 criteria.
  • Adverse events [ Time Frame: Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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.,
Other Name: TS-1
Experimental: Aiyi®
Tegafur Gimeracil Oteracil Potassium Capsule
Intervention: Drug: Tegafur Gimeracil Oteracil Potassium Capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2014
April 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years
No
Contact: Peng Yuan, MD 86-10-8778-8114 yuanpeng01@hotmail.com
China
 
NCT01492543
CH-BC-014
No
Binghe Xu, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
  • Beijing Cancer Hospital
  • Beijing Chao Yang Hospital
  • Chinese PLA General Hospital
  • China-Japan Friendship Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Hebei Tumor Hospital
Principal Investigator: Binghe Xu, MD, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP