Three Pillars Study

• Research type

  Research Study

• Full title

  3-Pillars Study: A phase II open label study of the cyclin-dependent kinase 4/6 inhibitor Palbociclib in combination with letrozole, trastuzumab plus tucatinib as neoadjuvant treatment for ER-positive, PgR-positive and HER2-positive early breast cancer in post-menopausal women

• IRAS ID

  1004806

• Contact name

  Carlo Palmieri

• Contact email

  C.Palmieri@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Eudract number

  2021-006077-34

• ISRCTN Number

  ISRCTN37422164

• Research summary

  This is a study where patients with early breast cancer will be given a combination of medication before they have their operation to remove the breast cancer. We want to look at whether this combination of drugs may be successful as a treatment for early breast cancer. We will be looking at post-menopausal women with early breast cancer that is ER-positive, PgR-positive and HER2-positive, and who are eligible for surgery.

  Breast cancer that has a significant number of receptors for either oestrogen (ER+) or progesterone (PgR+) is considered hormone-receptor positive and can be treated with either:
  • hormone therapy alone or;
  • chemotherapy followed by hormone therapy

  ER+ breast cancers are routinely treated with hormone therapy that block the oestrogen receptor, this type of therapy is more effective when combined with another drug which blocks a molecule called CDK4/6.
  About 15% of all breast tumours have higher levels of a protein known as HER2, called HER2-positive (HER2+) breast cancers. These cancers tend to grow and spread faster than breast cancers that are HER2-negative, but are much more likely to respond to routine treatment with drugs that target the HER2 protein. 50% of HER2+ breast cancers are also ER+. Research has shown that the combination of HER2 therapy with hormone therapy is more active than hormone therapy alone.

  This study will treat patients with early breast cancer that is ER+, PgR+ and HER2+ and will consist of a combination of treatments: letrozole to block oestrogen receptor (ER), plus trastuzumab and tucatinib to block HER2 and palbociclib to block CDK4/6.

  This study will take place in 10 hospitals across England, Wales and Scotland and 90 patients will take part over a period of 2 years.

  The results from this study will be used to help us improve treatments for postmenopausal women with ER+, PgR+ and HER2+ early breast cancer who require neoadjuvant therapy.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  23/LO/0388

• Date of REC Opinion

  14 Sep 2023

• REC opinion

  Further Information Favourable Opinion