Text Size

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

This study has been terminated.
(PI left VICC)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00082667
First received: May 14, 2004
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: gefitinib
Procedure: Surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

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 ]

Enrollment: 1
Study Start Date: October 2002
Study Completion Date: June 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gefitinib
    Other Name: ZD 1839, Iressa
    Procedure: Surgery
    Other Name: lumpectomy or mastectomy 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082667

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Meharry Medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mayer Mayer, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Ingrid Mayer, MD, Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00082667     History of Changes
Other Study ID Numbers: VICC BRE 0249, P30CA068485, VICC-BRE-0249
Study First Received: May 14, 2004
Last Updated: February 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
breast cancer in situ
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013