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

18 Years
Not Enrolling
Ductal Carcinoma in Situ

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Trial Information

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

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.

Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Patients with operable, biopsy-proven DCIS detected by screening mammography.

3. ER/PR negative DCIS.

4. DCIS that is positive for HER-2 &/or EGFR, which is defined as IHC 3+.

5. Women of childbearing potential willing to use an accepted and effective barrier
method of contraception.

6. ECOG performance status ≤2

7. Cardiac ejection fraction within the institutional range of normal as measured by

8. Ability to understand and the willingness to sign a written informed consent

9. 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:

1. Invasive breast cancer

2. ER+ or PR+ DCIS

3. Pregnant or breast feeding women

4. Patients who have had prior treatment with EGFR targeting therapies.

5. 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

6. 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.

7. HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with lapatinib.

8. Have ANY hepatic or biliary disease or dysfunction.

9. 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

10. Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.

11. ANY history of cardiac disease.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines. 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.

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Sunil Badve, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

August 2010

Related Keywords:

  • Ductal Carcinoma In Situ
  • DCIS
  • breast
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



Indiana University Indianapolis, Indiana  46202