Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
This study has been terminated.
(PI left VICC)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
First received: May 14, 2004
Last updated: February 22, 2013
Last verified: February 2013
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 gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
Primary Outcome Measures:
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery. [ Time Frame: at time of surgery, after 7-14 days of gefitinib ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients [ Time Frame: at time of surgery, after 7-14 days of gefitinib ] [ Designated as safety issue: No ]
- Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS [ Time Frame: at time of surgery, after 7-14 days of gefitinib ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Correlate levels of HER2 extracellular domain in ER-positive vs. ER-negative and in HER2-positive cs. HER2-negative patients [ Time Frame: at time of surgery, after 7-14 days of gefitinib ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2004 (Final data collection date for primary outcome measure)
Other Name: ZD 1839, Iressa
Other Name: lumpectomy or mastectomy of the breast
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by local surgery.
- Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.
- Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.
- Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib once daily for 7-14 days or until the day before local surgery. Patients then undergo lumpectomy or mastectomy.
- Arm II: Patients receive oral placebo once daily for 7-14 days or until the day before local surgery. Patients then undergo local surgery as in arm I.
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 (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Granulocyte count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin < 1.5 mg/dL
- SGOT ≤ 2 times upper limit of normal (ULN)
- SGPT < 1.5 times ULN
- PT and PTT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- No New York Heart Association class I-IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Random blood sugar < 2.5 times ULN
- No known hypersensitivity to study drug or its excipients
- No nonhealing wound or fracture
- No active infection
- No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
- No psychosis or severe depression
- No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
- No prior trastuzumab (Herceptin®)
- At least 1 year since prior chemotherapy
- No concurrent chemotherapy
- At least 1 year since prior aromatase inhibitors
- At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
- No concurrent glucocorticoids
- Concurrent oral contraceptives allowed
- Concurrent hormone replacement therapy allowed
- At least 1 year since prior radiotherapy
- No concurrent radiotherapy
- See Disease Characteristics
- Recovered from prior oncologic or other major surgery
- No prior organ allograft
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082667
|Meharry Medical College
|Nashville, Tennessee, United States, 37208 |
|Vanderbilt-Ingram Cancer Center
|Nashville, Tennessee, United States, 37232-6838 |
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
||Mayer Mayer, MD
||Vanderbilt-Ingram Cancer Center
||Ingrid Mayer, MD, Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
History of Changes
|Other Study ID Numbers:
VICC BRE 0249
|Study First Received:
||May 14, 2004
||February 22, 2013
||United States: Federal Government
Keywords provided by Vanderbilt-Ingram Cancer Center:
breast cancer in situ
ductal breast carcinoma in situ
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action