Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
NCT ID: NCT02188693
Last Updated: 2014-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
267 participants
OBSERVATIONAL
2014-07-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Gemcitabine, Experimental
Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause
No interventions assigned to this group
Observational
Observation for every 12 weeks until disease progression or the date of first documented death from any cause
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Xijing Hospital
OTHER
Responsible Party
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LiNanlin,Ph.D, Chief Physician,Clinical Professor
The department of Vascular endocrine surgery
Principal Investigators
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Li Nanlin, Ph.D
Role: STUDY_DIRECTOR
Air Force Military Medical University, China
Locations
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Xijing Hospital ， Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NLLY-01
Identifier Type: -
Identifier Source: org_study_id
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