Gemcitabine, Maintenance Chemotherapy, Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Eli Lilly and Company
Xijing Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From randomization to disease progression | 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 |
| PFS(progression free survival) | time from the date of randomization until the date of disease progression，assessed up to 3 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| QoL(quality of life) | the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years | the time from enrollment to disease progression or the date of first documented death,whichever comes first,to observe the quality of life in participants,assessed up to 3 years |
Countries
China
Contacts
Primary ContactLi Nanlin, Ph.D
Backup ContactChen Cong, Master
Outcome results
None listed