The ALTTO trial will enrol patients with HER2 (ErbB2)-positive early breast cancer who have completed surgery. Patients may be eligible to participate in ALTTO if they can answer YES to all  of the following questions:

• Have you been diagnosed with primary breast cancer (also known as early breast cancer)?
• Did you have one lump that was limited to the breast and was removed (or will soon be removed) by surgery?
• Was the tumour tested and found to be HER2 (ErbB2)-positive?
• Have you received, or will you receive, at least 4 cycles of chemotherapy containing an anthracycline?
• You also should NOT have had any previous anti-HER2 (ErbB2) therapy, for example, trastuzumab (Herceptin^®) or lapatinib.

There are some additional eligibility criteria that need to be evaluated by the study doctors.

Herceptin is a registered trade mark of Genentech, Inc.

To make sure that patients are eligible for the ALTTO trial, their doctors will perform several tests called screening tests. These tests include:

• Testing a sample of the tumour (tumour biopsy)
• Reviewing the patient's medical history and current medications
• Physical examination, including blood pressure, pulse and heart rate, and height and weight measurement
• Heart tests
  – Electrocardiogram (which measures the heart's rhythm)
  – Echocardiogram or MUGA scan (which tests how the heart pumps blood)
• Chest x-ray
• Mammogram
• Collection of blood sample (to conduct laboratory tests)
• For women who are able to become pregnant, a pregnancy test will also be performed from a urine or blood sample

In order to participate in the ALTTO trial, the investigators have to be sure that the breast cancer is HER2 (ErbB2)-positive. The patient's doctor will send away a sample of tumour that was collected and stored either at the time of diagnosis or when the tumour was removed. This sample of the tumour will be tested by a central laboratory to find out how much HER2 it contains. If the tumour is found to have very little or no HER2 protein (known as HER2-negative), the patient would probably not benefit from the treatments being tested in this trial. If the tumor is found to contain HER2 (known as HER2-positive), the patient may be eligible to participate in the ALTTO trial.

If you think you or someone you know may be eligible to participate in ALTTO, speak to your doctor or contact the trial sponsors (select "Contact information" at left).