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EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast


Phase 2
35 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

EGFR Pathway Modulation In Patients 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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.

Outcome Time Frame:

at time of surgery, after 7-14 days of gefitinib

Safety Issue:

No

Principal Investigator

Mayer Mayer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC BRE 0249

NCT ID:

NCT00082667

Start Date:

October 2002

Completion Date:

June 2005

Related Keywords:

  • Breast Cancer
  • breast cancer in situ
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Meharry Medical CollegeNashville, Tennessee  37208-3599