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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Tegafur Gimeracil Oteracil Potassium Capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: TS-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate	Assessed by RECIST v1.1 criteria.	Every six weeks
Adverse events		Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; Tianjin Medical University Cancer Institute and Hospital; Beijing Chao Yang Hospital; China-Japan Friendship Hospital; Hebei Tumor Hospital
• Investigators: Principal Investigator: Binghe Xu, MD, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Estimate): March 15, 2013
• Last Update Submitted That Met QC Criteria: March 14, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Breast cancer; Advanced; Metastatic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: CH-BC-014