Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy

Study Overview
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Brief Summary
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The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.

Official Title
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Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Drug: Pemetrexed
* Drug: Gemcitabine
* Drug: Gemcitabine
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel). Less than 3 different chemotherapy treatments for metastatic disease. Prior treatment with hormonal and/or radiation therapy. Must have disease that can be measured. Must be able to take care of self needs for example personal hygiene Exclusion Criteria: Must not be pregnant or breast-feeding. Cancer that has spread to the brain. Treatment with Gemcitabine or Pemetrexed Unable to take folic acid or Vitamin B12 Treatment for another cancer within the last 5 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 14 days, until disease progression<br>* Other names: LY231514, Alimta;Drug: Gemcitabine<br>* 1500 mg/m2, intravenous (IV), every 14 days, until disease progression<br>* Other names: LY188011, Gemzar;|
| Experimental: B<br> | Drug: Gemcitabine<br>* 1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression<br>* Other names: Gemzar;Drug: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days, until disease progression<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Tumor Response | Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria. | Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of (Confirmed) Complete Response or Partial Response | Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12). | Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated | 
| Time to Progressive Disease | Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12). | Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated | 
| Time to Treatment Failure | Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12) | Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated | 
| Overall Survival | Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12). | Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Breast, Cancer of the Breast