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
  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
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

Contacts
Contact: Peng Yuan, MD 86-10-8778-8114 yuanpeng01@hotmail.com

Locations
China, Beijing
Beijing Chao-yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Dan Yu, MD    +86-13810292522    xiaoyugw@126.com   
Principal Investigator: Hong Dai, MD         
Sub-Investigator: Dan Yu, MD         
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Donggui Wan, MD    +86-13601365686    dongguiwan@263.net   
Principal Investigator: Donggui Wan, MD         
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Huihui Rao, MD    +86-15110047147    15110047147@163.com   
Principal Investigator: Junlan Yang, MD         
Sub-Investigator: Huihui Rao, MD         
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Lijun Di, MD    +86-8819-6406    Dilijun2012@gmail.com   
Principal Investigator: Lijun Di, MD         
China, Hebei
Hebei Provincial Tumor Hospital Recruiting
Shijiazhuang, Hebei, China, 050019
Contact: Long Wang, MD    +86-13803343508    125662333@qq.com   
Principal Investigator: Wei Liu, MD         
Sub-Investigator: Long Wang, MD         
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Zhongsheng Tong, MD    +86-13920458207    tonghang@medmail.com   
Principal Investigator: Zhongsheng Tong, MD         
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Peng Yuan, MD    86-10-8778-8114    yuanpeng01@hotmail.com   
Principal Investigator: Binghe Xu, MD, PhD         
Sub-Investigator: Peng Yuan, MD         
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

No publications provided

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Tegafur
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014