Skip to content

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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00082667
Enrollment
1
Registered
2004-05-19
Start date
2002-10-31
Completion date
2005-06-30
Last updated
2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer in situ, ductal breast carcinoma in situ

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.

Interventions

DRUGgefitinib
PROCEDURESurgery

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.at time of surgery, after 7-14 days of gefitinib

Secondary

MeasureTime frame
Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patientsat time of surgery, after 7-14 days of gefitinib
Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCISat time of surgery, after 7-14 days of gefitinib

Other

MeasureTime frame
Correlate levels of HER2 extracellular domain in ER-positive vs. ER-negative and in HER2-positive cs. HER2-negative patientsat time of surgery, after 7-14 days of gefitinib

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026