Lapatinib and Trastuzumab With or Without Endocrine Therapy

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors.

The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Breast Care Center
• Collaborator: GlaxoSmithKline
• Treatments: Lapatinib; Trastuzumab

Criteria

Inclusion Criteria:

• All patients must be female.

• Signed informed consent.

• Locally advanced breast cancers or primary breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (If tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).

• HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of >5, or gene amplified.

• Negative serum pregnancy test (HCG) within 7 days of starting study, if of child-bearing potential.

• Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.

• Performance status (WHO scale) less than 2 and life expectancy more than 6 months.

• Age at least 18 years.

• No brain or leptomeningeal disease.

• No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.

Exclusion Criteria:

• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.

• Severe underlying chronic illness or disease.

• Cardiomyopathy or baseline LVEF less than 50%.

• Other investigational drugs while on study.

• Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.

• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded

• Taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (See Prohibited Medications List in protocol.)