Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Study Overview
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Brief Summary
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To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

Official Title
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Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically and/or cytologically confirmed breast cancer Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen To have at least one measurable region Eastern Cooperative Oncology Group (ECOG) Performance Status: 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 breast cancer Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery To have brain metastases with symptoms To have severe complication (cardiac infarction, infection, drug hypersensitivity 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> | Drug: gemcitabine<br>* Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1<br>* Other names: Gemzar;Drug: paclitaxel<br>* Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles<br>|

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. Responders are patients with complete response or partial response. | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | time of response to progressive disease | 
| Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | baseline to measured progressive disease | 
| Number of Participants Alive at One Year (1-Year Survival) |  | baseline to date of death from any cause, evaluated at 1 year | 
| Pharmacokinetics - Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) | 
| Pharmacokinetics - Area Under the Concentration Curve (AUC) | Area under the concentration curve from time zero to infinity. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) | 
| Pharmacokinetics - Half Life (t½) | Apparent elimination half-life. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |