A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With 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

Study Classification

INTERVENTIONAL

Brief Summary

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This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.

Detailed Description

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Gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection. Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.

Conditions

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Breast Neoplasms

Keywords

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metastatic breast cancer combination therapy Alimta

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

gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of breast cancer
* measurable disease
* received prior anthracycline and taxane
* life expectancy \> 3 months
* acceptable lab results

Exclusion Criteria

* \>3 prior regimens
* prior treatment with protocol drugs
* prior (pelvic) radiation
* active CNS metastasis
* inability to take oral vitamins

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Locations

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Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-MC-JMCF

Identifier Type: -

Identifier Source: secondary_id

2245