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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
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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

Sutton London Truro Birmingham Edinburgh Manchester

Medical Conditions

HER2-positive Breast Cancer

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

Publications

"Hurvitz SA, Loi S, O'Shaughnessy J, Okines AFC, Tolaney SM, Sohn J, Saura C, Zhu X, Cameron D, Bachelot T, Hamilton E, Curigliano G, Wolff AC, Harbeck N, Masuda N, Vahdat L, Zaman K, Valdes-Albini F, Block M, Pluard T, Tan TJ, Gawryletz C, Chan A, Bedard PL, Yerushalmi R, Xu B, Schmitt M, Xie D, Borges VF; HER2CLIMB-02 study investigators. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol. 2025 Nov 17:S0923-7534(25)06263-5. doi: 10.1016/j.annonc.2025.11.005. Online ahead of print."; "41260264"

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.

  • The Royal Marsden NHS Foundation Trust
    Sutton
    SM2 5PT
  • The Royal Marsden NHS Foundation Trust
    London
    SW3 6JJ
  • The Royal Cornwall Hospital
    Truro
    Cornwall
    TR1 3LJ
  • University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
    Birmingham
    B15 2TH
  • "Edinburgh Cancer Centre, Western General Hospital,"
    Edinburgh
    Scotland
    EH4 2XU
  • The Christie NHS Foundation Trust
    Manchester
    M20 4BX


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




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Read full details for Trial ID: NCT03975647
Last updated 03 December 2025

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