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TerminatedNCT00082667Updated Feb 25, 2013

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

A Phase 2 interventional study of gefitinib and Surgery in Breast Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 2 sites in United States. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment

Why this study was terminated
PI left VICC
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
35 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • breast cancer in situ
  • ductal breast carcinoma in situ
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 1 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1 participant (actual)

Interventions

  • Druggefitinib

    Also known as: ZD 1839, Iressa

  • ProcedureSurgery

    Also known as: lumpectomy or mastectomy of the breast

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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 outcomes

  1. 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

07

Study locations

2 sites
  • Meharry Medical College
    Nashville, Tennessee 37208, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00082667
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Ingrid Mayer, MD (Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
May 19, 2004
Start date
Oct 2002
Primary completion
Jul 2004
Completion
Jun 2005
Last update
Feb 25, 2013

Study contacts

Mayer Mayer, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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