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
- Life Expectancy ≥ 3 Months
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- Age over 18 Years
- ...
- Life Expectancy ≥ 3 Months
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- Age over 18 Years
- 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.
- Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- Written Informed consent
- ECOG Performance Status 0-2
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
- Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- 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)
- Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
Exclusion Criteria
- Peripheral Neuropathy ≥ Grade 2
- Documented Parenchymal or Leptomeningeal Brain Metastasis
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- ...
- Peripheral Neuropathy ≥ Grade 2
- Documented Parenchymal or Leptomeningeal Brain Metastasis
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- 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
- Prior Treatment With Gemcitabine Will Not be 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
- Life Expectancy ≥ 3 Months
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- Age over 18 Years
- ...
- Life Expectancy ≥ 3 Months
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- Age over 18 Years
- 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.
- Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- Written Informed consent
- ECOG Performance Status 0-2
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
- Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- 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)
- Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
Exclusion Criteria
- Peripheral Neuropathy ≥ Grade 2
- Documented Parenchymal or Leptomeningeal Brain Metastasis
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- ...
- Peripheral Neuropathy ≥ Grade 2
- Documented Parenchymal or Leptomeningeal Brain Metastasis
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- 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
- Prior Treatment With Gemcitabine Will Not be Allowed.
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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