Actively Recruiting
DETERMINE Trial Arm 04: Trastuzumab and Pertuzumab for Adult, Paediatric and Teenage/Young Adult Cancers With HER2 Amplification or Activating Mutations
Led by Cancer Research UK · Updated on 2025-12-02
30
Participants Needed
27
Research Sites
N/A
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
Researchers are evaluating a combination of drugs called trastuzumab and pertuzumab in patients with cancers that have a specific molecular change known as HER2 amplification or HER2 activating mutations. Although these drugs are already approved for certain breast cancers, this trial is studying their potential use in other rare and common cancers with these HER2 changes. The goal is to see if these drugs can be effective treatments for these additional cancer types and potentially become widely available through the NHS Cancer Drugs Fund. Patients in this trial will receive trastuzumab and pertuzumab through intravenous infusions every 21 days. Adults and children will get doses adjusted by weight, with initial loading doses followed by maintenance doses. Treatment continues until the cancer progresses, unacceptable side effects occur, or the patient chooses to stop. Before treatment, patients undergo biopsies and blood sample collection, which continue at different points during treatment and at the end. After treatment finishes, participants will be followed every three months for two years to monitor their health. Throughout the study, patients will have regular disease assessments up to 24 weeks after starting treatment, including scans and tests every two treatment cycles and quality of life surveys. Researchers will measure outcomes like tumor response, duration of benefit, survival times, and side effects related to the drugs. Safety monitoring will continue for up to five years after treatment ends. The trial also collects biological samples for research to better understand the cancers and treatment effects. The total participation time may last several years, including treatment and follow-up periods.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of a cancer with HER2 amplification or activating mutation as defined by molecular testing and the Molecular Tumour Board
- Age 12 years or older
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective birth control throughout treatment and for seven months after
- Male patients with partners of childbearing potential must agree to use contraception or abstinence during treatment and for seven months after
- Ability and willingness to undergo fresh tissue biopsy at baseline and blood sample collection for research
- Adequate organ function as confirmed by blood tests for both adult and paediatric patients
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 or within seven months after treatment
- Severe shortness of breath at rest or needing oxygen therapy due to advanced cancer
- Known allergy to trastuzumab, pertuzumab, murine proteins, or any ingredients
- Recent live, attenuated vaccine within 28 days before enrollment or expected need during treatment or within six months after
- Clinically significant heart conditions including uncontrolled angina, arrhythmias, heart failure (NYHA class III or IV), or low heart function (LVEF <55%)
- Recent stroke, transient ischemic attack, or heart attack within three months before treatment
- Prior treatment with the same drug class unless resistance profile supports treatment
- Any serious other disease or condition that could interfere with the study or pose risk
- Active infections including HIV unless well controlled with stable treatment and no recent opportunistic infections (last 12 months)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for biopsy and blood sample collection
Duration - Until disease progression, unacceptable adverse events, or withdrawal of consent
Participants receive trastuzumab and pertuzumab until disease progression without clinical benefit, unacceptable adverse events, or withdrawal of consent. Blood samples are collected at various intervals during treatment and at the end of treatment.
Intravenous infusions every 21 days with disease assessments every 6 weeks for up to 24 weeks, then possibly every 12 weeks
Duration - Up to 2 years after treatment ends
After completing treatment, participants are followed up every 3 months for 2 years to monitor health and outcomes.
Follow-up visits every 3 months
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
Research Team
A
Aida Sarmiento Castro
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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