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

Xijing Hospital267 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

267

Conditions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital ， Fourth Military Medical University

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From randomization to disease progression

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)

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

Time frame: the time from the date of randomization until the date of disease progression,assessed up to 3 years

Secondary Outcomes

OS(overall survival)

the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years

Time frame: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years

Central Contacts

Li Nanlin, Ph.D

CONTACT

+86-137-0911-3279 nanlin-74@163.com

Chen Cong, Master

CONTACT

+86-136-4929-4730 congcongfeiyang@126.com

Data from ClinicalTrials.gov

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