Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00082667

Purpose

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 giving gefitinib together with surgery works compared to surgery alone in treating women with ductal carcinoma in situ of the breast.

Condition	Intervention	Phase
Breast Cancer	Drug: gefitinib Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

• 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. [ Time Frame: after 30 days ] [ Designated as safety issue: No ]
• Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the effects of ZD1839 in ER-positive versus ER-negative DCIS and in HER2-positive versus HER2-negative DCIS. [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	October 2002
Study Completion Date:	June 2005
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

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.

Tertiary

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 nonapproved 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
- Neflinavir
- Nevirapine
- Oxcarbazepine
- Phenylbutazone
- Primidone
- Rifabutin
- Rofecoxib
- Sulfamethazine
- Sulfinpyrazone
- Troglitazone
No concurrent antiretroviral treatment for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082667

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Meharry Medical College
Nashville, Tennessee, United States, 37208

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Cristina I. Truica, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cristina Truica, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00082667 History of Changes
Other Study ID Numbers:	VICC BRE 0249, P30CA068485, VICC-BRE-0249
Study First Received:	May 14, 2004
Last Updated:	May 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:

breast cancer in situ
ductal breast carcinoma in situ

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012