tumors may benefit more than HER2+/HR+ tumors from dual HER2 blockade, according to 5-year results from the phase III ALTTO trial. The Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation study, or ALTTO, is an international phase III clinical trial of two targeted. Background: Pre-specified 5-year analyses of the phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial.

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The single-agent lapatinib arm was closed early due to futility, and the results of trkal arm will be presented later this year.

Meta-analysis of individual patient data for 10 women in 17 randomized trials. Correlative analyses of tissue samples is underway, and this may help to identify whether subsets of patients did benefit from the adjuvant combination. Email alerts New issue alert.

ALTTO recruited 8, patients between and Histologically confirmed Adequately excised exceptions: Any clinically staged T4 tumour, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1. Expert Point of View: Locoregional recurrence following breast cancer surgery in the trastuzumab era: Receive exclusive offers and updates alltto Oxford Academic.

See also Companion Articles Response. In view of this, the ALTTO trial was set up is to explore if lapatinib is also effective in patients with early disease who are given an adjuvant therapy treatment given after surgery.

Non-anthracycline platinum containing regimen docetaxel and carboplatin and study treatment must start concomitantly and no more than 14 days after randomisation. Sign In or Create an Account.


Patients with HER2-positive breast cancer have a greater risk of cancer recurrence due to the aggressiveness of this disease subtype. Randomisation must be performed no longer than 8 weeks from definitive triaal.

Breast Cancer Res Treat Patients must have received at least four cycles of an approved anthracycline-based neo- adjuvant chemotherapy regimen or listed as an exception in Table 5 of the protocol. Study treatment must start no more than 14 days after randomization and must be concurrent with taxanes.

The association between event-free survival and pathological complete response to neoadjuvant lapatinib, trastuzumab, or their combination in HER2-positive breast cancer. Serious cardiac illness or medical conditions including but not confined to: Presented December 11, Unresolved or unstable serious adverse events from prior adjuvant chemotherapy or radiotherapy; Malabsorption syndrome, any disease significantly affecting gastrointestinal function,or resection of the stomach or small bowel, or persons unable to swallow oral medication.


Published by Oxford University Press. Oxford University Press is a department of the University of Oxford. For the disease-free survival noninferiority analysis, the hazard ratio was 0. Patients will be followed for at least 10 years after enrolment; as alltto 1 Julyall patients had been followed for tgial least 5 years.

After surgery and a standard treatment with chemotherapy, patients enrolled in ALTTO were randomly assigned to receive one of these four treatments for a period of 1 year: Therefore, one year of trastuzumab as adjuvant treatment following surgery and chemotherapy with or without radiotherapy for this subtype of breast cancer remains the standard of care.

The recruitment opened in June and completed in July HER2-positive breast cancers are usually treated with aktto, which has been shown to lower the rate of cancer recurrence and improve survival when given with chemotherapy.


In this study, the distant recurrence events rate was higher in the RNI patients. Hazard ratios ranged from 0.

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options Design 2 and 2Band will be randomised to one of four treatment regimens within each design schema. At a median follow-up of 4. Regional nodal irradiation after breast-conserving surgery for early HER2-positive breast cancer: Lapatinib is another drug developed to treat HER2-positive breast cancer.

Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: By Caroline Helwick June 10, Advertisement. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. GlaxoSmithKline GSK was the sponsor and funder of the study until 30 Novafter which these responsibilities were transferred to Novartis.

The analysis by hormone receptor status was similar. As RNI clearly contributes to improving distant metastasis—free survival DMFS 23it is unclear why these rules, widely accepted in all BC patients, would be unsuitable for the more aggressive HER2-positive disease.