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

Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer

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

Study Overview

• Status: Unknown
• Conditions: Gemcitabine; Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer; Maintenance Chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 267

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital ， Fourth Military Medical University
      • Contact: Li Nanlin, Ph.D; Phone Number: +86-137-0911-3279; Email: nanlin-74@163.com
      • Contact: Chen Cong, Master; Phone Number: +86-136-4929-4730; Email: congcongfeiyang@126.com
      • Principal Investigator: Li Nanlin, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	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	From randomization to disease progression
PFS(progression free survival)		time from the date of randomization until the date of disease progression，assessed up to 3 years
PFS(progression free survival)	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	the time from the date of randomization until the date of disease progression,assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS(overall survival)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL(quality of life)	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	the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Eli Lilly and Company
• Investigators: Study Director: Li Nanlin, Ph.D, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NLLY-01