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A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal

Thank you

Trial Information

A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Tumor Response

Outcome Time Frame:

every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9028

NCT ID:

NCT00106002

Start Date:

April 2005

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms, Male
  • Carcinoma, Ductal
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Breast Neoplasms, Male
  • Carcinoma, Ductal

Name

Location
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. Bedford, Texas  76022