Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring HER2-positive breast cancer, Herceptin, trastuzumab
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
- HER2-positive breast cancer, defined as 3+ staining by IHC or gene amplification by FISH
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- Willingness to undergo a research biopsy of recurrent or metastatic disease
- Prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry.
- Completed radiation therapy at least 7 days prior to beginning protocol treatment
- Cohort 1: No prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other HER2-directed therapy other than trastuzumab
- Cohort 2: Up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other HER2-directed therapy except for trastuzumab
- 18 years of age or older
- Life expectancy of greater than 12 weeks
- ECOG Performance Status 0-2
- Normal organ and marrow function as outlined in protocol
- Cardiac ejection fraction, as assessed by either MUGA scan or echocardiogram greater than or equal to 50%
- Able to take oral medications
Exclusion Criteria:
- Patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease
- Active brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study
- Clinically significant malabsorption syndrome
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding women
- Concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
Sites / Locations
- University fo Alabama at Birmingham
- University of Chicago
- Dana-Farber at Faulkner Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Mayo Clinic
- University of North Carolina
- Vanderbilt University
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Other
Other
Cohort 1
Cohort 2
This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab