Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
...
Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
Life Expectancy ≥ 3 Months
Histologically Confirmed Metastatic, or Recurrent Breast Cancer
Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
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
Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
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.
Written Informed consent
No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer

Exclusion Criteria

Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
Pregnancy or Breast Feeding
Serious Uncontrolled Intercurrent Infections
...
Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
Pregnancy or Breast Feeding
Serious Uncontrolled Intercurrent Infections
Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
Peripheral Neuropathy ≥ Grade 2
Documented Parenchymal or Leptomeningeal Brain Metastasis
Prior Treatment With Gemcitabine Will Not be Allowed.
HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed

Summary

Conditions
  • Gemcitabine
  • Maintenance Chemotherapy
  • Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 70 years
Gender
Only females

Inclusion Criteria

Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
...
Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
Life Expectancy ≥ 3 Months
Histologically Confirmed Metastatic, or Recurrent Breast Cancer
Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
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
Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
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.
Written Informed consent
No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer

Exclusion Criteria

Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
Pregnancy or Breast Feeding
Serious Uncontrolled Intercurrent Infections
...
Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
Pregnancy or Breast Feeding
Serious Uncontrolled Intercurrent Infections
Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
Peripheral Neuropathy ≥ Grade 2
Documented Parenchymal or Leptomeningeal Brain Metastasis
Prior Treatment With Gemcitabine Will Not be Allowed.
HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed

Locations

Xi'an, Shaanxi, 710032
Xi'an, Shaanxi, 710032

Tracking Information

NCT #
NCT02188693
Collaborators
Eli Lilly and Company
Investigators
Study Director: Li Nanlin, Ph.D Air Force Military Medical University, China