Breast Cancer Clinical Trial
Official title:
A Phase I Study of Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer
Verified date | April 2014 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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, they may also have stereotactic radiosurgery (SRS). Lapatinib s a compound that may stop cancer cells from growing abnormally. It is thought that lapatinib might also make cancer cells more sensitive to radiation. This drug has been used in other research studies in women with breast cancer, and information from those other research studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the brain and outside the brain.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 2012 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Nancy Lin, MD | Breast Cancer Research Foundation, Brigham and Women's Hospital, GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer. | The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects. | 5 Years | Yes |
Secondary | Progression Free Survival | Progression Free Survival is the time from date of start of treatment to the date of the first documented progression or death due to any cause. If a patient has not progressed or died, progression free survival is censored at the time of last tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 5 years | No |
Secondary | Objective Response Rate in Central Nervous System Sites | Objective Response Rate was defined using volumetric response as the following: Complete Response (CR) is the disappearance of all target lesions, stable/responsive non-target lesions, and no new lesions. Partial response (PR) is at least a 50% reduction in the sum of the target lesions, stable/responsive non-target lesions, and no new lesions. Stable Disease (SD) is neither CR PR or Progressive Disease (PD). And Progressive Disease (PD) is at least 40% increase in sum of target lesionsor the appearance of any new lesion >=6mm in the longest dimension. If a patient progressed in a non-central nervous system(CNS) site first, died, or withdrew from the study for any reason after the first dose of drug was administered, and before a CR or PR in the central nervous system was determined, she was considered a CNS non-responder. | 5 years | No |
Secondary | Percentage of Participants Having Central Nervous System as the Site of the First Progression | 5 years | No | |
Secondary | Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression | 5 years | No | |
Secondary | Overall Survival | Overall average length of participant survival after protocol initiation | Participants were followed for an average of 3.8 years | No |
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