ALTTO TRIAL PDF
December 25, 2019 | by admin
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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Histologically confirmed Adequately excised exceptions: Serious cardiac illness or medical conditions including but wltto confined to: Regional nodal irradiation after breast-conserving surgery for early HER2-positive breast cancer: The analysis by hormone receptor status was similar. Presented December 11, Any clinically staged T4 tumour, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1.
The following dosing schemes were used:. It works inside alhto cells to slow or stop the processes that cause tumour growth and disease progression.
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.
ALTTO Trial (BIG ) | Breast International Group
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. The association between event-free survival and pathological complete response to neoadjuvant lapatinib, trastuzumab, or their combination in HER2-positive breast cancer.
Sign In or Create an Account. It is mentioned that RNI was defined as follows: Piccart-Gebhart noted in her presentation. GlaxoSmithKline GSK was the sponsor and funder of the study until 30 Novafter which these responsibilities were transferred to Novartis.
J Trjal Cancer Inst. The single-agent lapatinib arm was closed early due to futility, and the results of that arm will be presented later this year.
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. For Permissions, please e-mail: Meta-analysis of individual patient data for 10 women in 17 randomized teial.
Summary Eligibility for people ages 18 years and up full criteria Location at San Francisco, California and other locations Dates study started May 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.
The impact of loco-regional radiotherapy RT on survival of patients with high risk of metastases could be questioned. These patients have a higher risk of relapse than patients with luminal lesions in both trjal pretrastuzumab 56 and trastuzumab altt 7.
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. Correlative analyses of tissue samples is underway, and this may help to identify whether subsets of patients did benefit ttrial the adjuvant combination.
It was the largest-ever adjuvant clinical trial in HER2-positive breast cancer, involving 8, women from centers in 44 countries, Dr. Patients with hormone receptor—positive cancers also received appropriate hormonal therapy. In addition to the coordinating partners, 19 academic research groups from the BIG network are participating in alttp study.
If several lesions are found to be HER2 positive locally, the largest lesion should be considered altti central review. At a median follow-up of 4.
Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: Breast Cancer Res Treat Email alerts New issue alert. As the discussant of this paper at the Plenary Session, George W.