ALTTO TRIAL PDF

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. 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. Lapatinib is another drug developed to treat HER2-positive breast cancer. It works inside the cells to slow or stop the processes that cause tumour growth and disease progression. When the study was designed, it was thought that using both drugs combined or in sequence might work better than giving either drug alone.

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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. 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. Lapatinib is another drug developed to treat HER2-positive breast cancer.

It works inside the cells to slow or stop the processes that cause tumour growth and disease progression. When the study was designed, it was thought that using both drugs combined or in sequence might work better than giving either drug alone.

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. 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. Researchers reported the cardiac data from 4, patients who did not have any serious cardiac illness and who received one year of adjuvant trastuzumab alone, or trastuzumab and lapatinib concomitantly.

Symptoms of heart failure in these patients were assessed tri-monthly during treatment, every 6 months until 2 years of treatment, and then once a year until 10 years after start of treatment.

It was found that dual HER2 blockade does not increase the rate of cardiotoxicity in comparison to trastuzumab alone.

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

Study treatment must start no more than 14 days after randomization and must be concurrent with taxanes. For Design 2B: Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen docetaxel and carboplatin and study treatment must start concomitantly and no more than 14 days after randomisation. Equivocal local results may be submitted for a final determination by the central laboratory. 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. Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded from this study. Any clinically staged T4 tumour, including inflammatory breast cancer; Bilateral tumours; This exclusion criterion has been removed as of protocol amendment 1.

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

HER2 is expressed at high levels in up to 25 percent of all breast cancers. Tumors that overproduce HER2 are generally more aggressive and more likely to recur than those that do not. Researchers sought to find out whether one drug is better than the other at helping women live longer without a recurrence of their disease, or if the two drugs work better together. Women with HER2-positive breast cancer whose tumors had been completely removed by surgery were eligible to join. On September 9, , the leadership of ALTTO announced that the lapatinib only arm of the trial was being discontinued.

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Negative ALTTO Results Reverberate for Lapatinib, Novel Clinical Trials

Perez, MD A dual HER2-blockade strategy that added lapatinib to trastuzumab for the adjuvant treatment of women with early breast cancer failed to demonstrate a significant improvement in disease-free survival DFS over the standard therapy with trastuzumab alone, according to findings from a major clinical trial released Sunday. As a result, the findings may deal a blow to an emerging movement to establish pCR as a clinical trial endpoint in earlier disease settings not only in breast cancer but also in other malignancies, experts said. The ALTTO trial, which enrolled more than women in 44 countries, is the largest adjuvant clinical trial ever conducted in women with HER2-positive breast cancer and the findings were eagerly anticipated in the oncology community. Released at the American Society of Clinical Oncology ASCO Annual Meeting, the findings indicated that treatment with lapatinib plus trastuzumab, either sequentially or concurrently, was associated with a high rate of DFS but that combining the drugs did not produce a statistically significant advantage over trastuzumab alone. At a median follow-up of 4. All patients also received chemotherapy. The results proved to be a disappointment to researchers pursuing a new approach for reducing the risk of relapse for women treated after surgery with trastuzumab and chemotherapy.

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