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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The following dosing schemes were used:. Perez reported no potential conflicts of interest. 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. Hazard ratios ranged from 0. Non-anthracycline platinum containing regimen docetaxel and carboplatin and study treatment must start concomitantly and no more than 14 days after randomisation.

A protocol-specified updated efficacy analysis is planned in 2 years. Randomisation must be performed no longer than 8 weeks from definitive surgery. 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 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. These patients have a higher risk of relapse than patients with luminal lesions in both the pretrastuzumab 56 and trastuzumab eras 7.

Study treatment must start no more than 14 days after randomization and must be concurrent with taxanes. J Natl Cancer Inst.

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

Perez did find something positive in the results, as she noted to the media that the disease-free events that occurred at 4.

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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. Related articles in Google Scholar. For full disclosures of all the study authors, visit abstracts.

Equivocal local results may be submitted for a final determination by the central laboratory. Effect of radiotherapy after breast-conserving surgery on year recurrence and year breast cancer death: Receive exclusive offers and updates from Oxford Academic.

Patients will be followed for at least 10 years after enrolment; as of 1 Julyall patients had been followed for at least 5 years. Correlative analyses of tissue samples is underway, and this may help to identify whether subsets of patients did benefit from the adjuvant combination. Sign In or Create an Account. 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: It was the largest-ever adjuvant clinical trial in HER2-positive breast cancer, involving 8, women from centers in 44 countries, Dr. Any clinically staged T4 tumour, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1.

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

Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded from this study. We trail Gingras et al. By Caroline Helwick June 10, Advertisement.

For Permissions, please e-mail: Patients with HER2-positive breast cancer have a greater risk of cancer recurrence altt to the aggressiveness of this disease subtype. 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.

Given trkal of these points, we have doubts about the conclusions of the ALTTO-retrospective findings for obvious reasons: This study is in progress, not accepting new patients. Patients with hormone receptor—positive cancers also received appropriate hormonal therapy. Email alerts New issue alert. In addition to the coordinating partners, 19 academic research groups from the BIG network are participating in this study.

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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. At a median follow-up of 4. Treatment Controversy Eva M.

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You CAN’T join if Meta-analysis of individual patient data for 10 women in 17 randomized trials. 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 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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The recruitment opened in June and completed in July Summary Eligibility for people ages 18 years and up full criteria Location at San Francisco, California and other locations Dates study started May As the discussant of this paper at the Plenary Session, George W. GlaxoSmithKline GSK was the sponsor and funder of the study until 30 Novafter which these responsibilities were transferred to Novartis.

For the disease-free survival noninferiority analysis, the hazard ratio was 0. When the study was designed, it was thought that using both drugs combined or in sequence might work better than giving either drug alone. Locoregional recurrence following breast cancer surgery in the trastuzumab era: Epub Jan Breast cancer subtype approximated by estrogen receptor, progesterone receptor, and HER-2 is associated with local and distant recurrence after breast-conserving therapy.