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

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

• Registration Number: NCT02188693
• Lead Sponsor: Xijing Hospital

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 available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Study First Posted: 2014-07-14
• Last Update Posted: 2014-07-14
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 267

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	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)	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital ， Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China