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A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane


Inclusion Criteria:



- Have been diagnosed with metastatic or recurrent breast cancer.

- Have been previously treated with both an anthracycline and a taxane.

- Have not received more than two prior chemotherapy treatment programs.

- Have stopped any antitumoral hormonal treatment before you enroll in this study.

- Have a negative pregnancy blood test if menstruating or capable of becoming pregnant.
You must use an approved birth control method during the study and for 3 months
after stopping study treatment.

Exclusion Criteria:

- Cannot follow the study procedures (for example, you can not swallow tablets)

- Are receiving another treatment for your cancer.

- Have received another experimental drug in the last 4 weeks.

- Have had serious heart disease within last 6 months.

- Are pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

baseline to measured progressive disease

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:

10536

NCT ID:

NCT00437294

Start Date:

March 2007

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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