Suspended

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

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What is being tested

gefitinib

+ Surgery
Drug
Procedure
Who is being recruted

Breast Cancer

Over 35 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2002

Summary

Principal SponsorVanderbilt-Ingram Cancer Center
Last updated: February 25, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2002Actual date on which the first participant was enrolled.

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. 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.

Official TitleEGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast 
Principal SponsorVanderbilt-Ingram Cancer Center
Last updated: February 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1 patient to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 35 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Meharry Medical CollegeNashville, United StatesSee the location
Suspended
Vanderbilt-Ingram Cancer CenterNashville, United States

Suspended2 Study Centers