EORTC 90091-10093
Research type
Research Study
Full title
Trastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumour Cells (CTC) (“Treat CTC“ trial)
IRAS ID
124625
Contact name
Anthony Kong
Contact email
Sponsor organisation
EORTC
Eudract number
2009-017485-23
Clinicaltrials.gov Identifier
Research summary
HER2 is a protein which is present on some cancer cells. When the HER2 receptor is present in greater numbers (known as HER2-positive), it can cause the cancer to grow faster. These patients benefit from the drug trastuzumab. But patients in early stage cancer who have low numbers of the HER2 receptor (known as HER2-negative) still relapse despite receiving the optimal treatment. This does not currently include trastuzumab.
Some women with breast cancer have rare abnormal cells called “circulating tumour cells“ (CTC) circulating in their blood. The test to detect these cells is called a CTC blood test. Studies have shown that women with a positive CTC blood test are at a higher risk of their cancer coming back, but these studies were very small so the results don’t provide strong proof. Some women who are HER2-negative have a positive CTC blood test. Even healthy women had a positive CTC blood test. So we don’t know what a positive CTC blood test means for HER2-negative women who are currently cancer free.
Currently there is no evidence that trastuzumab benefits women with a positive CTC blood test. Therefore it would not normally be prescribed to patients with HER2-negative breast cancer.
The aim of this study is to evaluate whether a course of treatment with trastuzumab can reduce the detection by CTC blood tests of CTC in HER2-negative patients who are currently cancer-free following surgery for breast cancer (including if they had radiotherapy or chemotherapy. If this study shows evidence of fewer positive CTC blood tests in women treated with trastuzumab, then future trials will be able to evaluate the clinical benefits of trastuzumab in cancer treatment. This trial will therefore randomly place women into an observation group or a trastuzumab group to assess the benefits of trastuzumab on CTC.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0629
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion