Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

Completed · Not applicable · Has a placebo group

Conditions studied: Ductal Breast Carcinoma In Situ, HER2/Neu Positive

In brief

This randomized phase I/II trial studies the side effects and best dose of lapatinib ditosylate and to see how well it works in treating patients with ductal breast carcinoma in situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00555152

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2009-08-19

Expected to finish

2014-08-28

Last updated by the study team

2018-04-20

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be premenopausal or postmenopausal
• Participants must have a diagnosis of ductal carcinoma in situ made by core needle biopsy
• The DCIS cells must have high expression of human epidermal growth factor receptor 2 (erbB2) (3+ by immunohistochemical staining or amplification by fluorescence in situ hybridization [FISH]), and/or have detectable expression of epidermal growth factor receptor (EGFR) (1+ or more by immunohistochemical staining)
• All participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• Individuals with a diagnosis of breast cancer, non-melanoma skin cancer, cervical cancer in situ, or early bladder cancer are eligible if they have not been treated with chemotherapy, biological therapy, or breast radiotherapy to the breast currently affected by DCIS within one year; in addition, individuals with a diagnosis of breast cancer may not have used tamoxifen, raloxifene, or other antiestrogen compounds within three months of study day 1
• If subjects are of reproductive potential, they must agree to use a reliable contraceptive method or be sexually abstinent; subjects must fulfill these conditions beginning at the time of starting study medications and ending one month after study termination
• Negative serum pregnancy test (beta-human chorionic gonadotropin [HCG]) at baseline (within 30 days of day 0) for women of child bearing potential
• Serum creatinine =< 1.5 times the institution?s upper limit of normal
• Total bilirubin =< 1.5 times the institution's upper limits of normal
• Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 times the institution's upper limits of normal
• Alkaline phosphatase =< 1.5 times the institution's upper limits of normal
• Albumin =< 1.5 times the institution's upper limits of normal
• White blood cells (WBC) > 4.0 k/uL
• Platelet count > 100,000/uL
• Hematocrit of > 30%
• Cardiac ejection fraction within normal limits for the institution by multi gated acquisition scan (MUGA) scan or normal cardiac ultrasound (defined as within the upper limit of normal [ULN] for the institution)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Willingness to refrain from donating blood to others during the study

You may not qualify if…

• Individuals are ineligible if they have either active cancer or a prior history of malignancies other than (e.g., breast cancer, skin cancer [basal or squamous cell carcinoma], cervical cancer in situ, or early bladder cancer [preinvasive transitional cell carcinoma of the bladder]) within the past five years
• Participants are ineligible if they are currently being treated with tamoxifen, raloxifene, or with aromatase inhibitors (letrozole, anastrozole, exemestane)
• Individuals are ineligible if they have received chemotherapy, biological therapy (e.g., Herceptin), or radiotherapy for the treatment of any cancer within 1 year or if they have received tamoxifen, raloxifene, letrozole, anastrozole, or exemestane therapy within 3 months of study day 1
• Individuals currently receiving anticoagulation therapy (e.g., Coumadin) are ineligible
• Blood urea nitrogen [BUN] > 1.5 x ULN or
• Creatinine [Cr] > 1.5 x ULN
• SGOT > 1.5 x ULN
• Serum glutamate pyruvate transaminase (SGPT) > 1.5 x ULN
• Alkaline phosphatase > 1.5 x ULN
• Bilirubin > 1.5x ULN
• Individuals who are currently participating in a study of an investigational drug
• Pregnancy, lactation or unwillingness to use a reliable contraceptive method in women of childbearing potential
• Severe underlying chronic illness or disease, such as uncontrolled diabetes
• Individuals with known congestive heart disease or previous myocardial infarction are ineligible
• Patients taking any prohibited medications
• Individuals with hypokalemia or hypomagnesemia are ineligible unless these conditions are corrected to within normal limits before starting drug
• Individuals with congenital long QT syndrome or baseline QTcF intervals > 480 msec on electrocardiogram (EKG)
• Individuals taking anti-arrhythmics, beta blockers, or other medications that may lead to QT prolongation
• Individuals who have received a cumulative dose of anthracycline therapy greater than 500 mg/m\^2 are ineligible

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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