Histologically Confirmed Metastatic, or Recurrent Breast Cancer
Age over 18 Years
ECOG Performance Status 0-2
Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
Life Expectancy ≥ 3 Months
Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
Prior Radiation Therapy Allowed as Long as \< 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
Written Informed consent
You may not be if
Serious Uncontrolled Intercurrent Infections
Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
Pregnancy or Breast Feeding
Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
Documented Parenchymal or Leptomeningeal Brain Metastasis
Peripheral Neuropathy ≥ Grade 2
Prior Treatment With Gemcitabine Will Not be Allowed.
HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
Clareo Health | Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
