Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment

Official Title
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Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer

Conditions
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Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer, Gemcitabine, Maintenance Chemotherapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gemcitabine, Experimental<br>Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause | |
| Observational<br>Observation for every 12 weeks until disease progression or the date of first documented death from any cause | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | From randomization to disease progression | 
| PFS(progression free survival) |  | time from the date of randomization until the date of disease progression，assessed up to 3 years | 
| PFS(progression free survival) | PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years | the time from the date of randomization until the date of disease progression,assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS(overall survival) | the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years | the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years |