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NEO21-RS

NEOTYPE (NEO21-RS): A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadjuvant therapy in ER-positive intermediate recurrence score primary breast cancer

NEO21-RS

NEOTYPE (NEO21-RS): A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadjuvant therapy in ER-positive intermediate recurrence score primary breast cancer
Funding Pfizer, Genomic Health
Portfolio Cancer
Interventions Medicine
Randomised Yes
Status Funding awarded/in set-up
Start Date 01-Jan-0001

The NEO21-RS study will look at two different treatments for breast cancer given before Surgery to remove the tumour. Treatment given before having Surgery is called neoadjuvant therapy. Treatment before Surgery is given to try and shrink the tumour and will be either hormone therapy or chemotherapy.

Early estrogen receptor positive (ER+) breast cancer can be treated with either hormone therapy alone or with chemotherapy followed by hormone therapy. These treatments can be given after Surgery to reduce the risk of the breast cancer returning or before Surgery to help shrink the breast cancer as well as reduce the risk of the breast cancer returning. It is known that ER+ breast cancers generally respond less well to chemotherapy and that not all such cancers need chemotherapy. Given all the possible side effects of chemotherapy it is important we try and avoid treating women in whom it will provide little or no benefit.

In many patients with estrogen receptor positive tumours who have their breast cancers removed as their first treatment doctors can use a test called the Oncotype DX Breast Recurrence Score® to help them make decisions around the possible benefit of chemotherapy and if it is needed to treat their breast cancer. The test uses breast cancer tissue and analyses a set of genes. At the moment the test is not available when treatment is needed before Surgery to shrink the breast cancer.

The Oncotype DX Breast Recurrence Score® currently places breast cancers into 3 groups
1. Low RS breast cancers have a lower risk of their cancer returning and do not benefit from chemotherapy so hormone therapy is recommended.
2. High RS breast cancers have a greater chance of their cancer returning and chemotherapy is recommended. Endocrine therapy is given once chemotherapy has been completed.
3. Intermediate RS breast cancers (i.e. in the middle), in these cancers the benefit and need for chemotherapy is not known. There is therefore a case by case discussions with each individual patient with some patients being treated with chemotherapy and some without chemotherapy. Therefore, patients in this group are often treated with hormone therapy alone.

There are 2 components to this study:
• An observational study of the outcomes for patients whose tumours have a low and high Recurrence Score (RS), where we will follow them up to see how they get on with their treatment
• A randomised trial to compare two different treatments for patients whose tumours have an intermediate RS breast cancers. Half will receive hormone therapy on its own and the other half will have hormone therapy plus a new drug called palbociclib.

This study will take place in several hospitals across England, Wales and N. Ireland and 118 patients will take part over a period of 2 years.

Publications

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