Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00097383
First received: November 22, 2004
Last updated: July 18, 2006
Last verified: July 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: ALIMTA plus Epirubicin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097383
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097383
Locations
| 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 | |
| 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 | |
| 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, Belgium | |
| 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. | |
| 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. | |
| 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. | |
| Sorocaba, 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 | |
| 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. | |
| 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. | |
| Mexico City, Mexico | |
| 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, Portugal | |
Sponsors and Collaborators
Eli Lilly and Company
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00097383 History of Changes |
| Other Study ID Numbers: | 4028, H3E-MC-JMDU |
| Study First Received: | November 22, 2004 |
| Last Updated: | July 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Epirubicin Antibiotics, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015