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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In this study, the distant recurrence events rate was higher in the RNI patients. Patients with hormone receptor—positive cancers also received appropriate hormonal therapy. As the discussant of this paper at the Plenary Session, George W.

Non-anthracycline platinum containing regimen docetaxel and carboplatin and study treatment must start concomitantly and no more than 14 days after randomisation. Breast Cancer Res Treat Breast cancer subtype approximated by estrogen receptor, progesterone receptor, and HER-2 is associated with local and distant recurrence after breast-conserving therapy.

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

The single-agent lapatinib arm was closed early due to futility, and the results of that arm will be presented later this year. If the patient is node-negative: Treatment Controversy Eva M. The following dosing schemes were used:. Lapatinib is another drug developed to treat HER2-positive breast cancer.

At a median follow-up of 4. 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. Epub Jan The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival DFS.

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Histologically confirmed Adequately excised exceptions: See also Companion Articles Response. A protocol-specified updated efficacy analysis is planned in 2 years. It works inside the cells to slow or stop the processes that cause tumour growth and disease progression.

Oxford University Press is a department of the University of Oxford. The current efficacy results were based on 6, patients randomized.

Jumping higher: is it still possible? The ALTTO trial challenge.

Patients with Aptto breast cancer have a greater risk of cancer recurrence due to the aggressiveness of this disease subtype. For Permissions, please e-mail: 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.

Perez reported no potential conflicts of interest. Patients with any prior diagnosis of breast cancer or melanoma, triak any time, are excluded from this study. Receive exclusive offers and updates from Oxford Academic.

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If several alfto are found to be HER2 positive locally, the largest lesion should be considered for central review. Patients with a prior malignancy sltto 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.

This is not standard of care and is probably related to different practices in the participating countries. Expert Point of View: We congratulate Gingras et al. Presented June 1, Study treatment must start no more than 14 days after randomization For Design 2: Patients must have received at least four cycles of an approved anthracycline-based neo- adjuvant chemotherapy regimen or listed triwl an exception in Table 5 of the protocol.

By Caroline Helwick June 10, Advertisement.

ALTTO Trial (BIG ) | Breast International Group

Equivocal local results may be submitted for a final determination by the central laboratory. ALTTO recruited 8, patients between and Any clinically staged T4 tfial, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1.

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

Summary Eligibility for people ages 18 years and up full criteria Location at San Francisco, California and other locations Dates study started May Presented December 11, 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 trkal aggressive HER2-positive disease.

Completion of all necessary baseline laboratory and radiological investigations Signed written informed consent approved by ttial Independent Ethics Committee IEC and obtained prior to any study specific screening procedures. For the disease-free survival noninferiority analysis, the hazard ratio was 0. For full disclosures of all the study authors, visit abstracts.

The analysis by hormone receptor status was similar. Given all of these points, we have doubts about the conclusions of the ALTTO-retrospective findings for obvious reasons: It was the largest-ever adjuvant clinical trial altti HER2-positive breast cancer, involving 8, women from centers in 44 countries, Dr. Study treatment must start no more than 14 sltto after randomization and must be concurrent with taxanes.

Locoregional recurrence following breast cancer surgery in the trastuzumab era: Altro, injectable, or implant hormonal contraceptives are not indicated in this patient population ; Concomitant use of CYP3A4 inhibitors or inducers.

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