Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Trastuzumab; Cisplatin
Intervention description: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.; 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.; 30 mg/m2 IV on Day 1 and Day 8.
Intervention MeSH terms: Gemcitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic

Summary:

      This study determines the proportion of metastatic breast cancer patients progression free
      after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/
      trastuzumab.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Must have invasive metastatic breast cancer

          -  Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University
             pathology)or positive FISH

          -  Histological confirmation of invasive breast cancer either from the original diagnosis
             and/or diagnosis of metastatic disease.

          -  Tumor must be detectable clinically or radiographically (a positive bone scan is
             allowed as the only site of disease). Unidimensional measurements must be obtained
             whenever possible). Bone marrow only disease is not eligible for enrollment on this
             study.

          -  No evidence of congestive heart failure, symptoms of coronary artery disease, serious
             cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO.
             Patients must have normal LV function and LVEF(left ventricular ejection fraction)>
             50% as demonstrated by either echo or muga within the proceeding 4 weeks.

          -  Must have adequate renal and hepatic function documented by a serum creatinine < 1.5 x
             the institutional upper limit of normal (ULN), serum bilirubin <1.5 x ULN and liver
             enzymes (AST, ALT, or alkaline phosphatase) < 2 x ULN (< 5 x ULN if hepatic
             metastasis) within 21 days prior to registration.

          -  Patients must have an ANC (absolute neutrophil count) > 1.5, platelets > 100,000,
             Hemoglobin >9.0 within 21 days of registration.

          -  If patients are on bisphosphonates at the time of registration, with a stable
             creatinine over the preceding 2 months, then they may continue bisphosphonates during
             the study.

          -  No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination
             for metastatic disease. Additional Trastuzumab therapy may have been given in the
             adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic
             disease.

          -  Must be >3 weeks since administration of last chemotherapy prior to initiation of
             treatment on this trial. Prior trastuzumab may have been administered within one week
             of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior
             trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period.

          -  Patients may have received prior cisplatin or carboplatin for metastatic disease.

          -  No CNS(central nervous system)metastasis disease.

          -  No active infection at time of registration.

          -  Pregnant or nursing women may not participate in trial.

          -  Patients must be informed of the investigational nature of this study and sign and
             give written informed consent in accordance with institutional and federal guidelines.

          -  ECOG (Eastern Cooperative Oncology Group)performance status < 2 at the time of
             registration.

          -  Patients may participate in a non-treatment related protocol while participating in
             this study.

          -  No other active malignancy is allowed. Adequately treated basal cell, squamous cell
             skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from
             which the patient is currently in complete remission, or any other cancer from which
             the patient has been disease-free for 5 years is allowed.