Statement: There were no patients in either cohort of the primary trial with a PFS exceeding one year.
Primary_evidence: Outcome Measurement:    Progression Free Survival (PFS)   PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.   Time frame: 24 Months, End of Study (Up to 5 years) Results 1:    Arm/Group Title: Trastuzumab + Anastrozole   Arm/Group Description: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.   Overall Number of Participants Analyzed: 103   Median (95% Confidence Interval)   Unit of Measure: Months  24 Months: 4.8        (3.7 to 7)   End of Study: 5.8        (4.6 to 8.3) Results 2:    Arm/Group Title: Anastrozole   Arm/Group Description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.   Overall Number of Participants Analyzed: 104   Median (95% Confidence Interval)   Unit of Measure: Months  24 Months: 2.4        (2 to 4.6)   End of Study: 2.9        (2.1 to 4.5)