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

NCT02188693 | Unknown

• 1 other identifier: NLLY-01
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• PFS(progression free survival)

  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

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

Secondary Outcomes (1)

• OS(overall survival)

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

Other Outcomes (1)

• QoL(quality of life)

  the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Xijing Hospital ， Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

2 ml blood sample is needed before enrollment.

MeSH Terms

Conditions

Recurrence; Breast Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Li Nanlin, Ph.D

  Air Force Military Medical University, China

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The department of Vascular endocrine surgery

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

CN (1)