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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

Study acronym: DETERMINE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 155 words Secondary endpoints: details revised at 2 of 13 entries · Study description expanded, about 3 wordsv6 Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 13 entries
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 26 to 27 Eligibility criteria expanded, about 56 words · Secondary endpoints revised (13) · Study description revised · 1 morev5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints revised (13)
    • Study description revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 7 of 26 sitesv4
  4. Eligibility criteria revised Study description revised · Site details revised at 2 of 26 sites · Study title revisedv3 Show 3 more changesShow less
    • Study description revised
    • Site details revised at 2 of 26 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of Apr 2023 to Mar 7, 2023 Secondary endpoints: details revised at 2 of 13 entries · Site details revised at 3 of 26 sitesv2 Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 13 entries
    • Site details revised at 3 of 26 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cancer Research UK
15 trials monitored
See 2 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
and 4 more diseases
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.
Trial Details
NCT Number NCT05786716
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions Haematological Malignancy, Colorectal Neoplasms, Urinary Bladder Neoplasm, Gallbladder Neoplasms, Salivary Gland Neoplasm, Lung Neoplasm, Pancreatic Neoplasm, Ovarian Neoplasms +3 more
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov