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This study (ALTTO) evaluates post-surgery (adjuvant) Lapatinib and/or Trastuzumab in patients with surgically removed HER2-positive early-stage breast cancer. It included patients over 18 with confirmed HER2-positivity and adequate heart function. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key Inclusion Criteria: * Patients \>= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF \>= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =\< 1, were included. * For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception. * Approved, signed written informed consent obtained prior to any study specific screening procedures. Key Exclusion Criteria: * History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors. * Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer; * Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement. * Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa) * (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support; * Serious cardiac illness or medical conditions. * Any of the following abnormal laboratory tests immediately prior to randomization: 1. Serum total bilirubin \>1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\<2 x ULN) was allowed; 2. Alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 x ULN; 3. Alkaline phosphatase (ALP) \>2.5 x ULN; 4. Serum creatinine \>2.0 x ULN; 5. Total white blood cell count (WBC) \<2.5 x 10\^9/L; 6. Absolute neutrophil count \<1.5 x 10\^9/L; 7. Platelets \<100 x 10\^9/L. * Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women. * Concomitant use of CYP3A4 inhibitors or inducers.