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

NCT ID: NCT00082667

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-06-30

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

gefitinib

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

Other Intervention Names

ZD 1839, Iressa; lumpectomy or mastectomy of the breast

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Mayer, MD

Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mayer Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Meharry Medical College

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC-BRE-0249

Identifier Type: -

Identifier Source: secondary_id

VICC BRE 0249

Identifier Type: -

Identifier Source: org_study_id