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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Serious cardiac illness or medical conditions including but not confined to: The recruitment opened in June and completed in July It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide.

These patients have a higher risk of relapse than patients with luminal lesions in both the pretrastuzumab 56 and trastuzumab eras 7. By Caroline Helwick June 10, Advertisement. Piccart-Gebhart noted alltto her presentation.

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. It was the largest-ever adjuvant clinical trial in HER2-positive breast cancer, involving 8, women from centers in 44 countries, Dr. Close mobile search navigation Article navigation. Correlative analyses of tissue samples is underway, and this may help to identify whether subsets of patients did benefit from the adjuvant combination.

Effect of radiotherapy after breast-conserving altgo on year recurrence and year breast cancer death: Breast cancer subtype approximated by estrogen receptor, progesterone receptor, and HER-2 is associated with local and distant recurrence after breast-conserving therapy. If several lesions are found to be HER2 positive locally, the largest lesion should be considered for central review.

Treatment Controversy Eva M. 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.

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Meta-analysis of individual patient data for 10 women in 17 randomized trials. The current efficacy results were based on 6, patients randomized.

Patients will be followed for at least 10 years after enrolment; as of 1 Julyall patients had been followed for at least 5 years.

Patients with HER2-positive breast cancer have a greater risk of cancer recurrence due to the aggressiveness altho this disease subtype. It is mentioned that RNI was defined as follows: In addition to the coordinating partners, 19 academic research groups from the BIG network are participating in this study.

We congratulate Gingras et al.

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

Locoregional recurrence following breast cancer surgery in the trastuzumab era: Non-anthracycline platinum containing regimen docetaxel and carboplatin and study treatment qltto start concomitantly and no more than 14 days after randomisation.

J Natl Cancer Inst. Epub Jan Published by Oxford University Press. ALTTO recruited 8, patients between and Histologically confirmed Adequately excised exceptions: Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded from this study.

ALTTO Trial Finds Dual Anti-HER2 Therapy No Better Than Trastuzumab Alone

At a median follow-up of 4. See also Companion Articles Response. 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.

Secondary objectives include treatment comparisons with respect to overall survival, time trisl recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor.

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Any clinically staged T4 tumour, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1. Regional nodal irradiation after breast-conserving surgery for early HER2-positive breast cancer: 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.

Patients with hormone receptor—positive cancers also received appropriate qltto therapy. GlaxoSmithKline GSK was the sponsor and funder of the tdial until 30 Novafter which these responsibilities were transferred to Novartis.

ALTTO Trial (BIG ) | Breast International Group

Oxford University Press is a department of the University of Oxford. Email alerts New issue alert. As the discussant of this paper at the Plenary Session, George W.

Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: Study treatment must start no more than 14 days after randomization For Design 2: Presented December 11, Completion of all necessary baseline laboratory and radiological investigations Signed written informed consent approved by an Independent Ethics Committee IEC and obtained prior to any study specific screening procedures.

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: Hazard ratios ranged from 0.