ALTTO TRIAL PDF

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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Equivocal local results may be submitted for a final determination by the central laboratory. Receive exclusive offers and updates from Oxford Academic.

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

Regional nodal irradiation after breast-conserving surgery for early HER2-positive breast cancer: J Natl Cancer Inst. Published by Oxford University Press. At a median follow-up of 4. As the discussant of this paper at the Plenary Session, George W.

For Permissions, please e-mail: This is not standard of care and is probably related to different practices in the participating countries. Breast Cancer Res Treat altho Effect of radiotherapy after breast-conserving surgery on year recurrence and year breast cancer death: Study treatment must start no more than 14 days after randomization and must be concurrent with taxanes.

Serious cardiac illness or medical conditions including but not confined to: For full disclosures of all the study triql, visit abstracts. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide.

Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy chemotherapy or endocrine are eligible for the study.

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Patients will be followed for at least 10 years after enrolment; as of 1 Julyall patients had been followed for at least 5 years. Presented December 11, Sign In or Create an Account. In this study, the distant recurrence events rate was higher in the RNI patients.

The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the alttp alone arm was unlikely to meet the pre-specified altho to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival DFS.

You CAN’T join if HER2-positive breast cancers are usually treated with trastuzumab, which has been shown to lower the rate of cancer recurrence and improve survival when given with chemotherapy. It was the largest-ever adjuvant clinical trial in HER2-positive breast cancer, involving 8, women teial centers in 44 countries, Dr.

These patients have a higher trkal of relapse than patients with luminal lesions in both the pretrastuzumab 56 and trastuzumab eras 7.

A protocol-specified updated efficacy analysis is planned in 2 years. Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen docetaxel trila carboplatin and study treatment must start concomitantly and no more than 14 days after randomisation. Perez emphasized that failure to meet the primary endpoint—improved outcomes with dual HER2 blockade—was unexpected.

IBCSG 36-07/BIG 2-06 (ALTTO)

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.

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GlaxoSmithKline GSK was the sponsor and funder of the study until 30 Novafter which these responsibilities were transferred to Novartis. ALTTO recruited 8, patients between and Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: When the study was designed, it was thought that using both drugs combined or in sequence might work better than giving either drug alone. Patients with alttk receptor—positive cancers also received appropriate hormonal therapy.

Correlative analyses of tissue samples is underway, and this may help to identify whether subsets of patients did benefit from the adjuvant combination.

For the disease-free survival noninferiority analysis, the hazard ratio was 0. Perez reported no potential conflicts of interest.

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. In view of this, the ALTTO trial was set up is to explore if lapatinib is also alttoo in patients with early disease who are given an adjuvant therapy treatment given after surgery. Email alerts New issue alert. It also assessed the safety of lapatinib and aims to identify specific molecular markers indicators found in blood or other human tissue to predict which patients will benefit most from lapatinib or trastuzumab.