Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

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

Official Title
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A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dose Level 1 - 1000 mg/m2 | Drug: gemcitabine<br>* 1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days<br>* Other names: Gemzar;|
| Experimental: B<br>Dose Level 2 - 1250 mg/m2 | Drug: gemcitabine<br>* 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | 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. | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | 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 of response to progressive disease | 
| Time to 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. | baseline to measured progressive disease | 
| Survival at 1 Year | Results are reported as number of participants alive at one year. | baseline to date of death from any cause, evaluate at 1 year | 
| Pharmacokinetics - Normalized Cmax | maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine. | cycle 1 | 
| Pharmacokinetics - Normalized Area Under the Curve | Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter. | cycle 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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after, anthracycline, taxane, regimen