Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
2 other identifiers
interventional
N/A
5 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
25 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2004
CompletedFirst Posted
Study publicly available on registry
November 23, 2004
CompletedJuly 19, 2006
July 1, 2006
November 22, 2004
July 18, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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La Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Brussels, Belgium
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Leuven, Belgium
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Wilrijk, Belgium
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Maceió, Alagoas, Brazil
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Belo Horizonte, BH, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, Sao Paulo/SP, Brazil
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São Paulo, São Paulo, Brazil
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Sorocaba, São Paulo, Brazil
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Col. Campestre Churubusco, Mexico
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Mexico City, Mexico
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Arquiparque-Miraflores, Alges, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Proto, Portugal
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Santa Maria da Feira, Portugal
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Santarém, Portugal