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ANZ 0702 / BIG 2-06 : ALTTO - Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study

Trial Status:	Closed to screening

Treatment type:	Chemotherapy

Stage of Disease:	Early

Intent of Treatment:	Anticancer

Title:

A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer.

Summary:

Not all breast cancers are the same however it is common for breast cancer cells to contain growth receptors on their surface. One particular type of growth receptor is known as HER2. Patients who have a tumour that contains larger than normal amounts of this HER2 receptor (HER2-positive) have a greater risk of the disease coming back following their initial treatment; this is because breast cancer of this type tends to grow faster.

The ALTTO trial is for women and men diagnosed with HER2-positive breast cancer. The aim of this study is to determine how effective lapatinib, trastuzumab, or a combination of these drugs are in preventing cancer from returning in patients with HER2-positive early breast cancer.

Trastuzumab is a drug which has been shown to be effective in the treatment of HER2-positive early breast cancer, and is thus regarded as a standard treatment for this type of breast cancer. Despite this a percentage of women with HER2- positive breast cancer will still relapse, thus there is a need for new and more effective therapies. Lapatinib is an investigational medicine that may slow or stop these cancer cells from growing and may prevent cancer from returning. Lapatinib has been used to treat patients with HER2-positive breast cancer, whose cancer has progressed (spread to other places in the body, known as advanced breast cancer) after treatment with Trastuzumab. Lapatinib in combination with chemotherapy has been shown to delay disease progression when compared to treatment with chemotherapy alone. Lapatinib also has activity against breast cancer that has spread to the brain (brain metastases). In patients who previously received trastuzumab and whose cancer spread to the brain, Lapatinib was shown to stabilize or cause these brain metastases to shrink. Following completion of standard chemotherapy, eligible participants will be randomised to one of 4 different treatment arms. The treatment duration for all patients is a total of 52 weeks.

The ANZ 0702 / BIG 2-06 / EGF106708 (ALTTO) study is being conducted in over 50 counties world wide including Australia and New Zealand and will involve approximately 8000 participants. 40 institutions within Australia and New Zealand will be participating in this study.

Coordinating Group:

Australia and New Zealand:
ANZ Breast Cancer Trials Group (ANZ BCTG)

International:

Breast International Group (BIG)

North Central Cancer Treatment Group (NCCTG)

For more information:

Visit the following website: ALTTOtrials.com

Women who are interested in taking part in a clinical trial should discuss this with their doctor. In addition, please view the links to other websites that provide general information about clinical trial participation.


	ANZ BCTG receives research infrastructure funding from the Cancer Institute NSW and the Australian Government through Cancer Australia Copyright © 2010 Australian New Zealand Breast Cancer Trials Group Limited. All Rights Reserved. Copyright & Disclaimer \| Privacy Policy