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

• ClinicalTrials.gov Identifier: NCT02188693
• Recruitment Status: Unknown
• First Posted: July 14, 2014
• Last Update Posted: July 14, 2014
• Sponsor: Xijing Hospital
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital

Study Description

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

Condition or disease
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer; Gemcitabine; Maintenance Chemotherapy

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 267 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
• Study Start Date: July 2014
• Estimated Primary Completion Date: July 2017
• Estimated Study Completion Date: December 2017

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. PFS [ Time Frame: 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
2. PFS(progression free survival) [ Time Frame: time from the date of randomization until the date of disease progression，assessed up to 3 years ]
3. PFS(progression free survival) [ Time Frame: 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 :

1. OS(overall survival) [ Time Frame: 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:

1. QoL(quality of life) [ Time Frame: the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years ]
   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

Biospecimen Retention:   Samples With DNA

2 ml blood sample is needed before enrollment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Contacts

Contact: Li Nanlin, Ph.D; +86-137-0911-3279; nanlin-74@163.com

Contact: Chen Cong, Master; +86-136-4929-4730; congcongfeiyang@126.com

Locations

China, Shaanxi

Xijing Hospital ， Fourth Military Medical University; Recruiting

Xi'an, Shaanxi, China, 710032

Contact: Li Nanlin, Ph.D +86-137-0911-3279 nanlin-74@163.com

Contact: Chen Cong, Master +86-136-4929-4730 congcongfeiyang@126.com

Principal Investigator: Li Nanlin, Ph.D

Sponsors and Collaborators

Xijing Hospital

Eli Lilly and Company

Investigators

• Study Director: Li Nanlin, Ph.D; Air Force Military Medical University, China

More Information

Additional Information:

• Responsible Party: LiNanlin,Ph.D, Chief Physician,Clinical Professor, The department of Vascular endocrine surgery, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT02188693
• Other Study ID Numbers: NLLY-01
• First Posted: July 14, 2014
• Last Update Posted: July 14, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases