Status:
COMPLETED
Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer
Lead Sponsor:
Nancy Lin, MD
Collaborating Sponsors:
Brigham and Women's Hospital
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the safety of combining lapatinib plus radiation in patients with breast cancer that has spread to the brain. Depending upon the participants cancer,...
Detailed Description
* Participant's will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks. On the first day of the treatment cycle, participants will take 1 lapa...
Eligibility Criteria
Inclusion
- Histologically or cytologically-confirmed invasive breast cancer
- HER2 overexpressing breast cancer defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by FISH
- At least one parenchymal brain metastasis
- Disease progression in the CNS as assessed by at least one of the following; new neurological signs or symptoms; new lesion(s) in the CNS on an imaging study; progressive lesions on an imaging study
- At least two weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or major surgery for cancer
- 18 years of age or older
- Life expectancy of greater than 12 weeks
- ECOG performance status 0-2
- Normal organ and marrow function as described in the protocol
- Left ventricular ejection fraction \> 50%
- Able to swallow and retain oral medications
Exclusion
- Prior WBRT
- Receiving any other investigational agents
- Concurrent chemotherapy, immunotherapy, biologic therapy or hormonal therapy for treatment of their cancer
- History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to herceptin or lapatinib
- Leptomeningeal carcinomatosis as the only site of CNS involvement
- Concurrent treatment with medications that are either inducers of inhibitors of CYP3A4
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents
- Other known contraindication to MRI
- Uncontrolled intercurrent illness
- History of other active malignancy except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00470847
Start Date
April 1 2007
End Date
June 1 2012
Last Update
May 22 2014
Active Locations (3)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115