search
Back to results

Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
Surgery
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer in situ, ductal breast carcinoma in situ

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS No invasive disease Not completely excised Epidermal growth factor receptor (EGFR) positive (> 10% of cells stained) Planned lumpectomy or mastectomy within the next 2-4 weeks Hormone receptor status: Estrogen receptor status known PATIENT CHARACTERISTICS: Age 35 and over Sex Female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Granulocyte count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic 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 Renal Creatinine < 1.5 mg/dL Cardiovascular No New York Heart Association class I-IV heart disease Pulmonary No acute asthma Other 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: Biologic therapy No prior trastuzumab (Herceptin®) Chemotherapy At least 1 year since prior chemotherapy No concurrent chemotherapy Endocrine therapy 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 Radiotherapy At least 1 year since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior oncologic or other major surgery No prior organ allograft Other Recovered from all prior therapy (except alopecia) More than 30 days since prior non-approved or investigational drugs No prior definitive local therapy No prior immunosuppressive therapy No prior gefitinib No other prior EGFR inhibitors No other concurrent cytotoxic drugs No concurrent warfarin for anticoagulation No concurrent CYP3A4 inducers, including any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum (St. John's wort) Ethosuximide Griseofulvin Nafcillin Nelfinavir Nevirapine Oxcarbazepine Phenylbutazone Primidone Rifabutin Rofecoxib Sulfamethazine Sulfinpyrazone Troglitazone No concurrent antiretroviral treatment for HIV-positive patients

Sites / Locations

  • Meharry Medical College
  • Vanderbilt-Ingram Cancer Center

Outcomes

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.

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
Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS

Full Information

First Posted
May 14, 2004
Last Updated
February 22, 2013
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00082667
Brief Title
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Official Title
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
PI left VICC
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer in situ, ductal breast carcinoma in situ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib
Other Intervention Name(s)
ZD 1839, Iressa
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
lumpectomy or mastectomy of the breast
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS No invasive disease Not completely excised Epidermal growth factor receptor (EGFR) positive (> 10% of cells stained) Planned lumpectomy or mastectomy within the next 2-4 weeks Hormone receptor status: Estrogen receptor status known PATIENT CHARACTERISTICS: Age 35 and over Sex Female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Granulocyte count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic 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 Renal Creatinine < 1.5 mg/dL Cardiovascular No New York Heart Association class I-IV heart disease Pulmonary No acute asthma Other 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: Biologic therapy No prior trastuzumab (Herceptin®) Chemotherapy At least 1 year since prior chemotherapy No concurrent chemotherapy Endocrine therapy 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 Radiotherapy At least 1 year since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior oncologic or other major surgery No prior organ allograft Other Recovered from all prior therapy (except alopecia) More than 30 days since prior non-approved or investigational drugs No prior definitive local therapy No prior immunosuppressive therapy No prior gefitinib No other prior EGFR inhibitors No other concurrent cytotoxic drugs No concurrent warfarin for anticoagulation No concurrent CYP3A4 inducers, including any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum (St. John's wort) Ethosuximide Griseofulvin Nafcillin Nelfinavir Nevirapine Oxcarbazepine Phenylbutazone Primidone Rifabutin Rofecoxib Sulfamethazine Sulfinpyrazone Troglitazone No concurrent antiretroviral treatment for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayer Mayer, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast

We'll reach out to this number within 24 hrs