Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
Last updated on September 2021Recruitment
- 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
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