Neoplasms, Breast
Conditions
Keywords
Lapatinib, Metastatic Breast Cancer, HERCEPTIN refractory
Brief summary
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
Interventions
DRUGGW572016
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent. * Histologically confirmed Stage IIIb or IV breast cancer. * Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine. * Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab. * Documented disease progression of the most recent treatment is required. * Archived tumor tissue available for testing. * Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST). * At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug. * Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed. * Able to swallow and retain oral medication. * Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan. * Adequate kidney and liver function. * Adequate bone marrow function.
Exclusion criteria
* Pregnant or lactating. * Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review. * Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel. * History of other malignancy. * Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent. * Active or uncontrolled infection. * Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure. * Known history of or clinical evidence of leptomeningeal carcinomatosis. * Active infection. * Concurrent cancer therapy or investigational therapy. * Use of oral or IV steroids. * Unresolved or unstable serious toxicity from prior therapy. * Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical benefit rate time to progression 4 and 6 month progression free survival overall survival | — |
Countries
Argentina, France, Germany, United Kingdom
Outcome results
None listed