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

NCT00082667 | Terminated Phase 2 DMC

• 3 other identifiers: VICC BRE 0249P30CA068485VICC-BRE-0249
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

breast cancer in situ; ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (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 surgery.

  at time of surgery, after 7-14 days of gefitinib

Secondary Outcomes (2)

• Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients

  at 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 DCIS

  at time of surgery, after 7-14 days of gefitinib

Other Outcomes (1)

• Correlate levels of HER2 extracellular domain in ER-positive vs. ER-negative and in HER2-positive cs. HER2-negative patients

  at time of surgery, after 7-14 days of gefitinib

Interventions

gefitinib DRUG

Also known as: ZD 1839, Iressa

Surgery PROCEDURE

Also known as: lumpectomy or mastectomy of the breast

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Gefitinib; Surgical Procedures, Operative; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Mastectomy

Study Officials

• Mayer Mayer, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 19, 2004
• Study Start: October 1, 2002
• Primary Completion: July 1, 2004
• Study Completion: June 1, 2005
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

US (2)