Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Cisplatin/Capecitabine
Intervention description: 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
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Triple Negative Breast Cancer, Cisplatin, Capecitabine

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.
    

Eligibility criteria:

        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