Breast Cancer Clinical Trial
Official title:
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
| NCT number | NCT00097383 |
| Other study ID # | 4028 |
| Secondary ID | H3E-MC-JMDU |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| First received | November 22, 2004 |
| Last updated | July 18, 2006 |
| Verified date | July 2006 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | 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 | 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 |
| 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 | 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 | |
| Brazil | 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. | Belo Horizonte | BH |
| Brazil | 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. | Curitiba | PR |
| Brazil | 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. | Maceio | AL |
| Brazil | 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 Alegre | RS |
| Brazil | 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. | Sao Paulo | Sao Paulo/SP |
| Brazil | 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. | Sao Paulo | SP |
| Brazil | 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. | Sao Paulo | |
| Brazil | 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 | SP |
| Mexico | 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 | 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. | Guadalajara | Jalisco |
| Mexico | 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 | Mexico D.F. |
| Mexico | 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 | |
| Portugal | 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. | Arquiparque-Miraflores | Alges |
| Portugal | 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. | Coimbra | |
| Portugal | 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. | Lisboa | |
| Portugal | 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 | 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. | Proto | |
| Portugal | 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. | Santa Maria Da Feira | |
| Portugal | 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. | Santarem |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Argentina, Belgium, Brazil, Mexico, Portugal,
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