Clinical trial NCT02188693: Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
Official title: Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Gemcitabine
Maintenance Chemotherapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2014-07-14
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: PFS
timeFrame: From randomization to disease progression
measure: PFS(progression free survival)
timeFrame: time from the date of randomization until the date of disease progression，assessed up to 3 years
measure: PFS(progression free survival)
timeFrame: the time from the date of randomization until the date of disease progression,assessed up to 3 years
Secondary outcomes:
measure: OS(overall survival)
timeFrame: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
Other outcomes:
measure: QoL(quality of life)
timeFrame: the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years
Locations:
city: Xi'an
country: China
facility: Xijing Hospital ， Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Li Nanlin, Ph.D
role: STUDY_DIRECTOR
References: