Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Breast Neoplasms, Male; Carcinoma, Ductal
• Interventions: Drug: pemetrexed

• Registration Number: NCT00106002
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-03-18
• Study First Submitted QC: 2005-03-18
• Study First Posted: 2005-03-21
• Study Start: 2005-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-23
• Status Verified: 2009-04
• Results First Submitted QC: 2009-05-29
• Last Update Submitted: 2009-05-29
• Results First Posted: 2009-06-01
• Last Update Posted: 2009-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Must have been diagnosed with either advanced or metastatic breast cancer.
• Chemotherapy has not been given for advanced or metastatic breast cancer.
• The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
• Able to carry out work of a light nature (for example, light housework, office work).
• Must be at least 18 years old.

Exclusion Criteria

• Have received prior bone marrow or peripheral stem cell transplantation.
• Have received prior chemotherapy for metastatic breast cancer.
• Are currently pregnant or breast-feeding.
• Have an active infection that your doctor decides will affect your safety.
• Are unable to take folic acid or vitamin B12.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Overall Tumor Response	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Time	every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up	Defined as the time from date of first dose to time of death due to any cause.
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)	every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up	Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
Duration of Tumor Response	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
Progression-Free Survival Time	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this 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.; 🇺🇸 Dallas, Texas, United States