Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- 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
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- ...
- 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
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- 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)
- ECOG Performance Status 0-2
- Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- Life Expectancy ≥ 3 Months
- 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)
- Age over 18 Years
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
Exclusion Criteria
- Prior Treatment With Gemcitabine Will Not be Allowed.
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- ...
- Prior Treatment With Gemcitabine Will Not be Allowed.
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- Serious Uncontrolled Intercurrent Infections
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- Peripheral Neuropathy ≥ Grade 2
- Pregnancy or Breast Feeding
- Documented Parenchymal or Leptomeningeal Brain Metastasis
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
- 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
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- ...
- 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
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- 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)
- ECOG Performance Status 0-2
- Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- Life Expectancy ≥ 3 Months
- 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)
- Age over 18 Years
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
Exclusion Criteria
- Prior Treatment With Gemcitabine Will Not be Allowed.
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- ...
- Prior Treatment With Gemcitabine Will Not be Allowed.
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- Serious Uncontrolled Intercurrent Infections
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- Peripheral Neuropathy ≥ Grade 2
- Pregnancy or Breast Feeding
- Documented Parenchymal or Leptomeningeal Brain Metastasis
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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