Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-12-31

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.

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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms, Male Carcinoma, Ductal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Interventions

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pemetrexed

600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No