Back to results

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

Primary Purpose

Ductal Carcinoma in Situ

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

lapatinib

About this trial

This is an interventional basic science trial for Ductal Carcinoma in Situ focused on measuring DCIS, breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Indiana University

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Number of patients with toxicity associated with short therapy with lapatinib will be reported.

Full Information

NCT ID

NCT00857714

First Posted

March 6, 2009

Last Updated

June 16, 2015

Sponsor

Indiana University

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00857714

Brief Title

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

Official Title

Lapatinib in the Treatment of Ductal Carcinoma in Situ of the Breast

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to low accrual

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indiana University

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Ductal carcinoma in situ (DCIS) of the breast is a pre-malignant lesion of the breast, which is associated with a marked increase in the likelihood of developing invasive breast cancer. Since DCIS tends to be associated with microcalcifications, it is detected with an increased frequency in patients being screened with mammographic techniques. The treatment of DCIS is based on a number of parameters; local treatment depends on the size of the lesion, grade and margins. The only systemic treatment currently available is in the form of endocrine therapy; it depends on the expression of estrogen receptor (ER). Randomized trials have shown that the treatment of DCIS with breast conserving therapy and radiation is as effective as simple mastectomy. The efficacy of tamoxifen in reducing the incidence of further invasive or non-invasive breast cancer has been established. In addition to surgery (with or without radiation), patients with ER positive disease also receive anti-estrogen therapy. Current guidelines do not recommend any additional therapy for ER-negative DCIS. The rationale for the proposed study is based on the observations that HER2 is expressed at high levels in higher grades of DCIS, which typically lack ER. In addition, an inverse relationship between ER expression and the expression of EGFR has also been demonstrated. Lapatinib is active against both these receptors and may have therapeutic action in ER negative DCIS. We propose to treat the patients with drug in the interval between biopsy diagnosis and definitive surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ductal Carcinoma in Situ

Keywords

DCIS, breast

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

lapatinib

Other Intervention Name(s)

Tykerb

Intervention Description

1500 mg lapatinib for 14-21 days

Primary Outcome Measure Information:

Title

Number of Patients Where Gene Signature Was Obtained.

Description

Time Frame

Up to 60 days

Secondary Outcome Measure Information:

Title

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

Description

Number of patients with toxicity associated with short therapy with lapatinib will be reported.

Time Frame

Up to 60 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunil Badve, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs