DETERMINE Trial Arm 04 Trastuzumab and Pertuzumab Treatment for Adults, Teens, and Children With Cancers Having HER2 Amplification or Activating Mutations

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.

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