N/A
N=3
Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ
Ductal Breast Carcinoma In Situ · HER2/Neu Positive
Bottom Line
View on ClinicalTrials.gov: NCT00555152 ↗Enrolled (actual)
3
Serious AEs
4.6%
Results posted
Nov 2015
Primary outcome: Primary: Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); Lapatinib Ditosylate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS) |
— | — |
| PRIMARY Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0 |
0; 0; 1; 2; 6; 3 | — |
| SECONDARY Incidence of Ductal Carcinoma in Situ Remaining at Resection |
2; 10; 10; 0; 0; 0 | 1 |
| SECONDARY Biomarker Analysis of Proliferation Markers |
— | — |
Summary
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.
Eligibility Criteria
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 = 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 = 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
Data sourced from ClinicalTrials.gov (NCT00555152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.