Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer

Phase 2

Brief Summary: It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.

Detailed Description: Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials. Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response. Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials. This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.

Recruitment & Eligibility

Inclusion Criteria

Written and signed informed consent prior to beginning specific protocol procedures.
Pathologically confirmed Estrogen Receptor(ER), Progesterone Receptor(PR) and Human Epidermal growth factor Receptor HER-2) negative ("triple negative") breast cancer and documented metastatic or locally advanced disease.

Measurable disease - with at least 1 lesion measurable by radiological method

KPS>=70
18 to 70 years old women
Previously treated with an anthracycline and a taxane
Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal receptor positive.
Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if HER2 positive
Laboratory requirements:
- Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl; Hemoglobin>=10 g/dl
- Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5 times UNL without liver metastasis or <=5.0 times if liver metastasis Glucose<=200 mg/dL
- Renal function Serum creatinine<=140 mol/l
Life expectancy of at least 12 weeks
Patients must be accessible for treatment and follow-up.
Patients should have recovered from the acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy, adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical) radiotherapy or major surgery

Exclusion Criteria

Women who are pregnant or breast feeding
History of brain and/or leptomeningeal metastases
Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
Psychiatric disorders or other conditions which would prevent pt. compliance
Other serious illness or medical condition:
Congestive heart failure, or unstable angina pectoris, previous history of myocardial infarction within 6 month prior to study entry, uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.
History of significant neurological or psychiatric disorders including psychotic disorders, dementia of seizures that would prohibit the understanding and giving of informed consent.
Active uncontrolled infection.
Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of Corticosteroids.
Inability to take and/or absorb oral medicine
Prior treatment with capecitabine and/or cisplatin
Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry

Arm && Interventions

Group	Intervention	Description
Cisplatin/Capecitabine	Cisplatin/Capecitabine	Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	6 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years
Number and Severity of Adverse Events of Patients Enrolled in This Trial	1 year	Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.
Overall Survival	3 years