Statement: in order to be eligible for the primary clinical trial, prospective patients must have their her2+ status verified and have an lvef at least at 50 percent
Primary_evidence: Inclusion Criteria:   For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner   Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible   Known and documented HER2-positive   Known and documented LVEF of at least 50 percent (%)   Adequate organ function   A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing Exclusion Criteria:   Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease   Pregnant or lactating women   Current clinical or radiographic evidence of central nervous system (CNS) metastases   Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting   History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy