OncoMatch/Clinical Trials/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
Is NCT05786716 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Trastuzumab and Pertuzumab for haematological malignancy.
Treatment: Trastuzumab · Pertuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Colorectal Cancer
Urothelial Carcinoma
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Ovarian Cancer
Prostate Cancer
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
Required: HER2 (ERBB2) amplification
Prior therapy
Cannot have received: HER2-targeted therapy (trastuzumab, pertuzumab)
Exception: unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to trastuzumab or pertuzumab
Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to trastuzumab or pertuzumab
Lab requirements
Blood counts
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol
Kidney function
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol
Liver function
Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol
Cardiac function
No clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), NYHA class III or IV congestive heart failure. Left Ventricular Ejection Fraction <55% excluded. No cerebrovascular event (including stroke or TIA) or cardiovascular event (including acute MI) within three months before first dose.
ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. PAEDIATRIC PATIENTS (<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), NYHA class III or IV congestive heart failure. Left Ventricular Ejection Fraction <55%. Patients with a cerebrovascular event (including stroke or transient ischaemic attack [TIA]) or cardiovascular event (including acute myocardial infarction [MI]) within three months before the first dose of trastuzumab and pertuzumab.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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