Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast

NCT00857714 | Terminated Results DMC

• 1 other identifier: 0812-11
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS.

Conditions

Ductal Carcinoma in Situ

Keywords

DCIS; breast

Outcome Measures

Primary Outcomes (1)

• Number of Patients Where Gene Signature Was Obtained.

  Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.

  Up to 60 days

Secondary Outcomes (1)

• Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.

  Up to 60 days

Interventions

lapatinib DRUG

1500 mg lapatinib for 14-21 days

Also known as: Tykerb

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years.
• Patients with operable, biopsy-proven DCIS detected by screening mammography.
• ER/PR negative DCIS.
• DCIS that is positive for HER-2 \&/or EGFR, which is defined as IHC 3+.
• Women of childbearing potential willing to use an accepted and effective barrier method of contraception.
• ECOG performance status ≤2
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients must have normal organ and marrow function as defined below:
• leukocytes ≥3,000/microL
• absolute neutrophil count ≥1,500/microL
• platelets ≥100,000/microL
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT(SGPT) within normal institutional limits
• creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault formula)

You may not qualify if:

• Invasive breast cancer
• ER+ or PR+ DCIS
• Pregnant or breast feeding women
• Patients who have had prior treatment with EGFR targeting therapies.
• Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded one week before starting lapatinib and for the duration of lapatinib therapy.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib.
• Have ANY hepatic or biliary disease or dysfunction.
• Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
• Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
• ANY history of cardiac disease.

Sponsors & Collaborators

• Indiana University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sunil Badve, MD
• Organization: IndianaU

sbadve@iupui.edu

317-491-6417

Study Officials

• Sunil Badve, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 8, 2015
• Results First Posted: July 8, 2015

Record last verified: 2015-06

Locations

US (1)