Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Official Title
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A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have been diagnosed with either advanced or metastatic breast cancer. Chemotherapy has not been given for advanced or metastatic breast cancer. The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery. Able to carry out work of a light nature (for example, light housework, office work). Must be at least 18 years old. Exclusion Criteria: Have received prior bone marrow or peripheral stem cell transplantation. Have received prior chemotherapy for metastatic breast cancer. Are currently pregnant or breast-feeding. Have an active infection that your doctor decides will affect your safety. Are unable to take folic acid or vitamin B12.

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>* 600 mg/m2, intravenous (IV), every 14 days until complete response or 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 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. | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE). | every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up | 
| Duration of Tumor Response | Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause. | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | 
| Progression-Free Survival Time | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | 
| Overall Survival Time | Defined as the time from date of first dose to time of death due to any cause. | every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up |