Actively Recruiting

Phase 2
Phase 3
Age: 12Years +
All Genders
NCT05786716

DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations

Led by Cancer Research UK · Updated on 2025-12-02

30

Participants Needed

27

Research Sites

342 weeks

Total Duration

On this page

Sponsors

C

Cancer Research UK

Lead Sponsor

U

University of Manchester

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

CONDITIONS

Official Title

DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of cancer with HER2 amplification or activating mutation defined by molecular testing
  • HER2 amplification copy number 5-9 requires discussion; copy number ≥10 fast-tracked for recommendation
  • Age 12 years or older
  • Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during study and for 7 months after last dose
  • Male patients must agree to contraception measures and refrain from sperm donation during study and for 7 months after last dose
  • Ability and willingness to undergo fresh tissue biopsy and blood sample collection for research
  • Adequate organ function as defined by haematological and biochemical tests for adults and pediatric patients
Not Eligible

You will not qualify if you...

  • Diagnosis of HER2-positive early or metastatic breast cancer
  • Female patients who are pregnant, breastfeeding, or planning pregnancy during trial or within 7 months after last dose
  • Severe breathing difficulty at rest or needing oxygen due to advanced cancer
  • Known allergy to trastuzumab, pertuzumab, murine proteins, or excipients
  • Receipt of live, attenuated vaccine within 28 days before enrollment or planned during treatment and up to 6 months after last dose
  • Significant pre-existing heart conditions including uncontrolled angina, arrhythmias, severe heart failure, or recent stroke or heart attack within 3 months
  • Left ventricular ejection fraction less than 55%
  • Prior treatment with same drug class unless genetic profile shows potential sensitivity
  • Any significant concurrent illness or condition that may interfere with study or pose unacceptable risk
  • Active infections that affect safety or efficacy assessment, including uncontrolled HIV infection

AI-Screening

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Trial Site Locations

Total: 27 locations

1

Belfast City Hospital

Belfast, United Kingdom, BT9 7AB

Actively Recruiting

2

University Hospital Birmingham

Birmingham, United Kingdom, B15 2TT

Actively Recruiting

3

Birmingham Children's Hospital

Birmingham, United Kingdom

Not Yet Recruiting

4

Bristol Royal Hospital for Children

Bristol, United Kingdom, BS2 8BJ

Actively Recruiting

5

Bristol Haematology and Oncology Centre

Bristol, United Kingdom, BS2 8ED

Actively Recruiting

6

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 OQQ

Actively Recruiting

7

Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Actively Recruiting

8

Cardiff Children's Hospital

Cardiff, United Kingdom, CF14 4XW

Not Yet Recruiting

9

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Actively Recruiting

10

The Beatson Hospital

Glasgow, United Kingdom, G12 OYN

Actively Recruiting

11

Royal Hospital for Children Glasgow

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

12

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

13

Alder Hey Hospital

Liverpool, United Kingdom, L14 5AB

Actively Recruiting

14

University College London Hospital

London, United Kingdom, NW1 2BU

Actively Recruiting

15

Guy's Hospital

London, United Kingdom, SE1 9RT

Actively Recruiting

16

Great Ormond Street Hospital

London, United Kingdom, WC1N 3JH

Actively Recruiting

17

Royal Manchester Children's Hospital

Manchester, United Kingdom, M13 9WL

Not Yet Recruiting

18

The Christie Hospital

Manchester, United Kingdom, M20 4BX

Actively Recruiting

19

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom, CH63 4JY

Actively Recruiting

20

Great North Children's Hospital

Newcastle, United Kingdom, NE1 4LP

Actively Recruiting

21

Freeman Hospital

Newcastle, United Kingdom, NE7 7DN

Actively Recruiting

22

Churchill Hospital

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

23

John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

24

Weston Park Hospital

Sheffield, United Kingdom, S10 2SJ

Actively Recruiting

25

Sheffield's Children's Hospital

Sheffield, United Kingdom, S10 2TH

Actively Recruiting

26

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

27

The Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

A

Aida Sarmiento Castro

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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