Phase 1 N=35 Treatment

Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Breast Cancer · Brain Metastases

Bottom Line

View on ClinicalTrials.gov: NCT00470847 ↗

Enrolled (actual)

Serious AEs

22.9%

Results posted

Jan 2014

Primary outcome: Primary: The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer. — 1250 milligrams

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Lapatinib (Drug); Whole Brain Radiation (Procedure); Herceptin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nancy Lin, MD
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.	1250	—
SECONDARY Progression Free Survival	4.8	—
SECONDARY Objective Response Rate in Central Nervous System Sites	79	—
SECONDARY Percentage of Participants Having Central Nervous System as the Site of the First Progression	23	—
SECONDARY Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression	46	—
SECONDARY Overall Survival	19	—

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, 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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00470847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.