drugset / Trial / 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

NCT05786716

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-03-07
Primary completion
2029-10
Completion
2029-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 7 mg/kg Intravenous
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous