A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00191347 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: pemetrexed Drug: gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer |
Study Start Date : | October 2004 |
Study Completion Date : | November 2005 |

- To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)
- To measure time-to-event efficacy variables including: time to objective tumor response for responding patients, duration of response for responding pts, time to treatment failure, time to progressive disease, progression free survival, overall survival

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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:
- Have a performance status of 0 to 2 on the ECOG performance status schedule.
- Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
- Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
- Have adequate organ function including the following
EXCLUSION:
1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.

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): NCT00191347
Canada, Ontario | |
For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Ottawa, Ontario, Canada |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours,EST) | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00191347 |
Other Study ID Numbers: |
9305 H3E-CA-S050 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Pemetrexed Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |