Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00072865 |
Recruitment Status :
Completed
First Posted : November 13, 2003
Last Update Posted : January 26, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Neoplasm Metastasis | Drug: Pemetrexed Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer |
Study Start Date : | June 2003 |
Study Completion Date : | September 2005 |

- antitumor activity
- duration of response;time to progressive disease;time to treatment failure

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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:
- Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
- No prior chemotherapy for locally advanced or metastatic breast disease.
- Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
- Adequate bone marrow, liver and kidney function
- RECIST criteria for disease status
Exclusion Criteria:
- Prior treatment with pemetrexed
- Pregnant or breast feeding
- Brain Metastasis
- unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

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): NCT00072865
Russian Federation | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Moscow, Russia, Russian Federation | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Saint Petersburg, Russia, Russian Federation |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00072865 |
Other Study ID Numbers: |
7771 H3E-MW-JMGJ |
First Posted: | November 13, 2003 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes |
Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |