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
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Condition or disease |
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Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Gemcitabine Maintenance Chemotherapy |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 267 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer |
Study Start Date : | July 2014 |
Estimated Primary Completion Date : | July 2017 |
Estimated Study Completion Date : | December 2017 |

Group/Cohort |
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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
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Observational
Observation for every 12 weeks until disease progression or the date of first documented death from any cause
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- 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
- 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
- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188693
Contact: Li Nanlin, Ph.D | +86-137-0911-3279 | nanlin-74@163.com | |
Contact: Chen Cong, Master | +86-136-4929-4730 | congcongfeiyang@126.com |
China, Shaanxi | |
Xijing Hospital , Fourth Military Medical University | Recruiting |
Xi'an, Shaanxi, China, 710032 | |
Contact: Li Nanlin, Ph.D +86-137-0911-3279 nanlin-74@163.com | |
Contact: Chen Cong, Master +86-136-4929-4730 congcongfeiyang@126.com | |
Principal Investigator: Li Nanlin, Ph.D |
Study Director: | Li Nanlin, Ph.D | Air Force Military Medical University, China |
Responsible Party: | LiNanlin,Ph.D, Chief Physician,Clinical Professor, The department of Vascular endocrine surgery, Xijing Hospital |
ClinicalTrials.gov Identifier: | NCT02188693 |
Other Study ID Numbers: |
NLLY-01 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | July 14, 2014 |
Last Verified: | July 2014 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |