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Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02188693
Recruitment Status : Unknown
Verified July 2014 by LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital

Tracking Information
First Submitted Date July 9, 2014
First Posted Date July 14, 2014
Last Update Posted Date July 14, 2014
Study Start Date July 2014
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2014)
  • PFS [ Time Frame: From randomization to disease progression ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
  • PFS(progression free survival) [ Time Frame: time from the date of randomization until the date of disease progression,assessed up to 3 years ]
  • PFS(progression free survival) [ Time Frame: the time from the date of randomization until the date of disease progression,assessed up to 3 years ]
    PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 10, 2014)
OS(overall survival) [ Time Frame: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years ]
the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 10, 2014)
QoL(quality of life) [ Time Frame: the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years ]
the time from enrollment to disease progression or the date of first documented death,whichever comes first,to observe the quality of life in participants,assessed up to 3 years
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
Official Title Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
Brief Summary The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
2 ml blood sample is needed before enrollment.
Sampling Method Non-Probability Sample
Study Population Patients with MBC exhibited disease control (complete response + partial response + stable disease) with first-line PG and were randomly assigned to maintenance chemotherapy or observation.
Condition
  • Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
  • Gemcitabine
  • Maintenance Chemotherapy
Intervention Not Provided
Study Groups/Cohorts
  • 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
  • Observational
    Observation for every 12 weeks until disease progression or the date of first documented death from any cause
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2014)
267
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically Confirmed Metastatic, or Recurrent Breast Cancer
  • 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 Uncontrolled Intercurrent Infections
  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02188693
Other Study ID Numbers NLLY-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
Study Sponsor Xijing Hospital
Collaborators Eli Lilly and Company
Investigators
Study Director: Li Nanlin, Ph.D Air Force Military Medical University, China
PRS Account Xijing Hospital
Verification Date July 2014