Status:
COMPLETED
Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
Lead Sponsor:
Nancy Lin, MD
Collaborating Sponsors:
GlaxoSmithKline
Novartis
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether pos...
Detailed Description
* Participants will be asked to undergo a biopsy of an area of the body where the cancer has spread. * Participants will be given a study medication-dosing calendar for each treatment cycle. Each trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00470704
Start Date
May 14 2007
End Date
August 20 2024
Last Update
December 19 2024
Active Locations (9)
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1
University fo Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Chicago
Chicago, Illinois, United States, 60452
3
Dana-Farber at Faulkner Hospital
Boston, Massachusetts, United States, 02130
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215