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

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

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