Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-09-30

Brief Summary

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This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

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Detailed Description

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Conditions

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Breast Cancer Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pemetrexed

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
* No prior chemotherapy for locally advanced or metastatic breast disease.
* Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
* Adequate bone marrow, liver and kidney function
* RECIST criteria for disease status

Exclusion Criteria

* Prior treatment with pemetrexed
* Pregnant or breast feeding
* Brain Metastasis
* unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No