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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Xijing Hospital
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT02188693
First received: July 9, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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


Condition
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Gemcitabine
Maintenance Chemotherapy

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • PFS [ Time Frame: From randomization to disease progression ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • PFS(progression free survival) [ Time Frame: the time from the date of randomization until the date of disease progression,assessed up to 3 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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

2 ml blood sample is needed before enrollment.


Estimated Enrollment: 267
Study Start Date: July 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02188693

Contacts
Contact: Li Nanlin, Ph.D +86-137-0911-3279 nanlin-74@163.com
Contact: Chen Cong, Master +86-136-4929-4730 congcongfeiyang@126.com

Locations
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         
Sponsors and Collaborators
Xijing Hospital
Eli Lilly and Company
Investigators
Study Director: Li Nanlin, Ph.D Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

Responsible Party: LiNanlin,Ph.D, Chief Physician,Clinical Professor, The department of Vascular endocrine surgery, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02188693     History of Changes
Other Study ID Numbers: NLLY-01
Study First Received: July 9, 2014
Last Updated: July 10, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014