Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00097383 |
Recruitment Status :
Completed
First Posted : November 23, 2004
Last Update Posted : July 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: ALIMTA plus Epirubicin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097383
Argentina | |
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 | |
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, Argentina | |
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 | |
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Ciudad De Buenos Aires, Argentina | |
Belgium | |
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 | |
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 | |
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Wilrijk, Belgium | |
Brazil | |
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Maceio, AL, Brazil | |
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Belo Horizonte, BH, Brazil | |
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Curitiba, PR, Brazil | |
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Porto Alegre, RS, Brazil | |
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Sao Paulo, Sao Paulo/SP, Brazil | |
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Sao Paulo, SP, Brazil | |
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Sorocaba, SP, Brazil | |
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Sao Paulo, Brazil | |
Mexico | |
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Guadalajara, Jalisco, Mexico | |
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Mexico, Mexico D.F., Mexico | |
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Col. Campestre Churubusco, Mexico | |
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Mexico City, Mexico | |
Portugal | |
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Arquiparque-Miraflores, Alges, Portugal | |
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Coimbra, Portugal | |
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Lisboa, 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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Santarem, Portugal |
ClinicalTrials.gov Identifier: | NCT00097383 |
Other Study ID Numbers: |
4028 H3E-MC-JMDU |
First Posted: | November 23, 2004 Key Record Dates |
Last Update Posted: | July 19, 2006 |
Last Verified: | July 2006 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epirubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |