Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Back

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London Sutton Birmingham Cambridge Edinburgh Headington London Maidstone Northwood Truro Manchester Newcastle Upon Tyne

Medical Conditions

Breast Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.

Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2019 Jun 2023

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 300mg given twice per day by mouth (orally)

Intervention Arm Group : Tucatinib + T-DM1;

Intervention Type : DRUG
Intervention Description : Given twice per day orally

Intervention Arm Group : Placebo + T-DM1;

Intervention Type : DRUG
Intervention Description : 3.6 mg/kg given into the vein (IV; intravenously) every 21 days

Intervention Arm Group : Placebo + T-DM1;Tucatinib + T-DM1;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sarah Cannon Research Institute UK
    London
    Other
    W1G 6AD
  • The Royal Marsden Hospital (Surrey)
    Sutton
    Other
    SM2 5PT
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham
    Other
    B15 2TH
  • Addenbrooke's Hospital
    Cambridge
    Other
    CB2 0QQ
  • The University of Edinburgh
    Edinburgh
    Other
    EH4 2XU
  • Oxford University Hospitals
    Headington
    Other
    OX3 7LE
  • The Royal Marsden NHS Foundation Trust (RM)
    London
    Other
    SW3 6JJ
  • Maidstone and Tunbridge Wells NHS Trust
    Maidstone
    Other
    ME16 9QQ
  • Mount Vernon Hospital, UK
    Northwood
    Other
    HA6 2RN
  • Royal Cornwall Hospitals NHS Trust
    Truro
    Other
    TR1 3LQ
  • The Christie NHS Foundation Trust
    Manchester
    Other
    M20 4GJ
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle Upon Tyne
    Other
    NE7 7DN


The study is sponsored by Seagen, a wholly owned subsidiary of Pfizer



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: NCT03975647
Last updated 24 February 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top