Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/22/2018
Start Date:August 19, 2009
End Date:August 28, 2014

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Neoadjuvant Trial of Lapatinib for the Treatment of Women With DCIS Breast Cancer

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.

PRIMARY OBJECTIVES:

I. Determine whether lapatinib (lapatinib ditosylate) therapy at the dose of 1000 mg results
in a statistically significantly lower rate of proliferation in ductal carcinoma in situ
(DCIS) breast cancer cells as measured by Ki67 when compared to placebo.

II. Determine the toxicity profile and frequency of adverse events in women with DCIS breast
cancer taking lapatinib at 1000 mg as compared to women taking placebo.

SECONDARY OBJECTIVES:

I. Determine whether lapatinib treatment affects the incidence of DCIS seen at the time of
surgical excision.

II. Determine whether treatment with lapatinib will modulate breast tissue histology or the
expression of specific biomarkers in normal and DCIS breast cancer cells.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lapatinib ditosylate orally (PO) once daily (QD) for 2-6 weeks until
the time of surgery.

ARM II: Patients receive placebo PO QD for 2-6 weeks until the time of surgery.

After completion of study treatment, patients are followed for 4-5 weeks.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
2
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Birmingham, AL
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Houston, Texas 77030
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Houston, TX
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