Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: gemcitabine

• Registration Number: NCT00191269
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-03
• Results First Submitted: 2009-03-23
• Results First Submitted QC: 2009-03-23
• Results First Posted: 2009-05-14
• Status Verified: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-10
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Histologically and/or cytologically confirmed breast cancer
• Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
• To have at least one measurable region
• PS: 0-1
• To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria

• To have Interstitial pneumonia or pulmonary fibrosis
• To have inflammatory carcinoma
• Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
• To have brain metastasis with symptom
• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	gemcitabine	Dose Level 1 - 1000 mg/m2
B	gemcitabine	Dose Level 2 - 1250 mg/m2

Primary Outcome Measures

Name	Time	Method
Tumor Response	baseline to measured progressive disease	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	time of response to progressive disease	For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
Time to Progressive Disease	baseline to measured progressive disease	Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
Survival at 1 Year	baseline to date of death from any cause, evaluate at 1 year	Results are reported as number of participants alive at one year.
Pharmacokinetics - Normalized Cmax	cycle 1	maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.
Pharmacokinetics - Normalized Area Under the Curve	cycle 1	Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Tokyo, Japan