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

This study has been terminated.
(PI left VICC)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082667
First Posted: May 19, 2004
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
May 14, 2004
May 19, 2004
February 25, 2013
October 2002
July 2004   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00082667 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
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 ]
Not Provided
 
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: gefitinib
    Other Name: ZD 1839, Iressa
  • Procedure: Surgery
    Other Name: lumpectomy or mastectomy of the breast
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
June 2005
July 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00082667
VICC BRE 0249
P30CA068485 ( U.S. NIH Grant/Contract )
VICC-BRE-0249
Yes
Not Provided
Not Provided
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Mayer Mayer, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP