Statement: All the primary trial subjects either had Progressive disease, Complete CNS objective response rate or partial response rate.
Primary_evidence: Outcome Measurement:    The Number of Participants With Central Nervous System (CNS) Best Overall Response   Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)   Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.   The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)   A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms   Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years Results 1:    Arm/Group Title: Cohort A   Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings   Overall Number of Participants Analyzed: 94   Measure Type: Count of Participants   Unit of Measure: Participants  Complete response (CR): 0   0.0%   Partial response (PR): 6   6.4%   Stable disease (SD): 40  42.6%   Progressive disease (PD): 40  42.6% Unknown: 8   8.5% Results 2:    Arm/Group Title: Cohort B   Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.   Overall Number of Participants Analyzed: 143   Measure Type: Count of Participants   Unit of Measure: Participants  Complete response (CR): 0   0.0%   Partial response (PR): 9   6.3%   Stable disease (SD): 46  32.2%   Progressive disease (PD): 70  49.0%   Unknown: 18  12.6%