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

NCT01492543 | Unknown Phase 2

• 1 other identifier: CH-BC-014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Advanced; Metastatic; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Up to 2 years

Secondary Outcomes (2)

• Clinical response rate

  Every six weeks

• Adverse events

  Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years

Study Arms (1)

Aiyi®

EXPERIMENTAL

Tegafur Gimeracil Oteracil Potassium Capsule

Drug: Tegafur Gimeracil Oteracil Potassium Capsule

Interventions

Tegafur Gimeracil Oteracil Potassium Capsule DRUG

Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg\*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,

Also known as: TS-1

Aiyi®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Peking University Cancer Hospital & Institute: collaborator
• Beijing Chao Yang Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Hebei Tumor Hospital: collaborator

Study Sites (7)

Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100036, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Hebei Provincial Tumor Hospital

Shijiazhuang, Hebei, 050019, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

titanium silicide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Binghe Xu, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, MD

CONTACT

86-10-8778-8114; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Medical Oncology

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (7)