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

Gemcitabine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02188693
• Other study ID #: NLLY-01
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: July 10, 2014
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2014
• Source: Xijing Hospital
• Contact: Li Nanlin, Ph.D
• Phone: +86-137-0911-3279
• Email: nanlin-74[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 267
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xijing Hospital , Fourth Military Medical University	Xi`an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Primary	PFS(progression free survival)		time from the date of randomization until the date of disease progression,assessed up to 3 years	Yes
Primary	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	Yes
Secondary	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	Yes