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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
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
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Drug: Tegafur Gimeracil Oteracil Potassium Capsule
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aiyi®
Tegafur Gimeracil Oteracil Potassium Capsule
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

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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492543

Locations
China, Beijing
Beijing Chao-yang Hospital
Beijing, Beijing, China, 100020
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Peking University Cancer Hospital
Beijing, Beijing, China, 100036
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Hebei
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, China, 050019
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
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
Investigators
Principal Investigator: Binghe Xu, MD, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Responsible Party: Binghe Xu, Deputy Director of Department of Medical Oncology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01492543     History of Changes
Other Study ID Numbers: CH-BC-014 
Study First Received: December 12, 2011
Last Updated: March 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Advanced
Metastatic
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016