Docetaxol combined with S1 treatment for locally adanced and/or metastatic breast cancer patients' clinical trail

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-12002221

Enrollment

Unknown

Registered

2012-02-27

Start date

2011-04-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

1:Docetaxol combined with S1

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged >=18 years; 2. KPS>=70; 3. Confirmed Pathologic diagnosis of locally adanced and/or metastatic breast cancer; 4. at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors guidelines; 5. Unused taxane drugs or taxane drugs not resistance(taxane drugs can be used in Adjuvant chemotherapy, but it must over 12 monthes; 6. Screening laboratory values within the fllowing parameters: Hemoglobin: >=10.0 g/dl; PLT >=100*10^9/L; acount Absolute neutrophil count (ANC)>=1.5*10^9/L, Serum Creatinine >=60ml/min, Total bilirubin <=1.5*upper limit of normal; AKP; AST and ALT<=2.5*UNL (no liver metastasis); for liver metastasis AKP; AST and ALT<=5*UNL; 7. Get informed consent before join this trail; 8. sterilization or postmenopausal women. All subjects who are not surgical sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 monthes after the last dose of test article. For women of childbearing potential,a negtive urine or serum pregnency test result before study entry; 9. Life expectancy at least 3 monthes.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and breast-feeding women; 2. Prior treatment for metastatic disease (not Adjuvant chemotherapy); 3. History of Known hypersensitivity of docetaxol and any its component; 4. active central nervous system (CNS) metastases,or not easy to control of the mental illness; 5. any other cancer within 5 years prior to screening, with the exception of contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin; 6. evidence of significant heart disease (eg: Congestive heart failure, coronary artery disease with symptoms, arrhythmia which Drug therapy can't control, or Myocardial infarction; 7. serious active infection or serious metabolic disorders patients; 8. unwillingness or unable to follow the research proposal, or unable to cooperate with follow-up; 9. to be considered and recognized unfit for this trail.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Countries

China

Contacts

Public ContactJunlan Yang

24103936@qq.com+86 13910890971

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026