Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	35 and over	NCI	VICC-BRE-0249 NCT00082667

Special Category: NCI Avon award trial

Objectives

Primary

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 local surgery.
2. Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.

Secondary

1. Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.

Tertiary

1. Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.

Entry 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

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 nonapproved 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
  • Neflinavir
  • Nevirapine
  • Oxcarbazepine
  • Phenylbutazone
  • Primidone
  • Rifabutin
  • Rofecoxib
  • Sulfamethazine
  • Sulfinpyrazone
  • Troglitazone
• No concurrent antiretroviral treatment for HIV-positive patients

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/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 78 patients (39 per treatment arm) will be accrued for this study within 1.5 years.

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.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Cristina Truica, MD, Principal investigator(Contact information may not be current)		Ph: 800-811-8480

Registry Information
Official Title		EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
Trial Start Date		2002-10-01
Registered in ClinicalTrials.gov		NCT00082667
Date Submitted to PDQ		2004-01-22
Information Last Verified		2006-09-28
NCI Grant/Contract Number		CA68485

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