Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

NCT ID: NCT00097383

Last Updated: 2006-07-19

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

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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ALIMTA plus Epirubicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
* Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
* Patients must have at least one measurable lesion in an area not previously irradiated.
* No chemotherapy at least 4 weeks prior to study enrollment.
* Signed informed consent from patient.

Exclusion Criteria

* Treatment with any drug within the last 30 days that has not received regulatory approval.
* Serious systemic disorders, including active infection.
* Significant cardiovascular disease.
* Pregnancy or breast feeding.
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

La Plata, Buenos Aires, Argentina

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Rosario, Santa Fe Province, Argentina

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Buenos Aires, , Argentina

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Ciudad de Buenos Aires, , Argentina

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Brussels, , Belgium

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Leuven, , Belgium

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Wilrijk, , Belgium

Site Status

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Maceió, Alagoas, Brazil

Site Status

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Belo Horizonte, BH, Brazil

Site Status

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Curitiba, Paraná, Brazil

Site Status

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Porto Alegre, Rio Grande do Sul, Brazil

Site Status

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São Paulo, Sao Paulo/SP, Brazil

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

São Paulo, São Paulo, Brazil

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Sorocaba, São Paulo, Brazil

Site Status

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Guadalajara, Jalisco, Mexico

Site Status

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Mexico City, Mexico City, Mexico

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Col. Campestre Churubusco, , Mexico

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Mexico City, , Mexico

Site Status

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Arquiparque-Miraflores, Alges, Portugal

Site Status

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Coimbra, , Portugal

Site Status

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Lisbon, , Portugal

Site Status

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Porto, , Portugal

Site Status

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Proto, , Portugal

Site Status

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Santa Maria da Feira, , Portugal

Site Status

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Santarém, , Portugal

Site Status

Countries

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Argentina Belgium Brazil Mexico Portugal

Other Identifiers

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H3E-MC-JMDU

Identifier Type: -

Identifier Source: secondary_id

4028

Identifier Type: -

Identifier Source: org_study_id