|
|
|
|
|
Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082667 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with surgery works compared to surgery alone in treating women with ductal carcinoma in situ of the breast.
Condition | Intervention | Phase |
Breast Cancer |
Drug: gefitinib Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | ZD1839 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast |
Estimated Enrollment: | 78 |
Study Start Date: | October 2002 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 78 patients (39 per treatment arm) will be accrued for this study within 1.5 years.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent CYP3A4 inducers, including any of the following:
United States, Tennessee | |||||
Vanderbilt-Ingram Cancer Center | |||||
Nashville, Tennessee, United States, 37232-6838 |
Vanderbilt-Ingram Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Cristina I. Truica, MD | Vanderbilt-Ingram Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000355152, VICC-BRE-0249 |
First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082667 |
Health Authority: | United States: Federal Government |
|
|
|
|
|