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New treatment option for Haematological Malignancy
Official 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
ClinicalTrials.gov ID: NCT05786716
What this study is testing
What is Trastuzumab?
Trastuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for haematological malignancy.
Also referred to as Herceptin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 04 (TRASTUZUMAB AND...
- \ When trastuzumab- and pertuzumab-specific inclusion/
You likely can't join if
- or precautions below differ from those specified in the Master Protocol, the trastuzumab- and pertuzumab-specific criteria will take precedence...
- A HER2 amplification copy number between 5-9 will require an MTB discussion. A HER2 amplification copy number ≥10 will be fast-tracked for an MTB...
- Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.
- Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an...
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the...
- Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of trastuzumab and...
See the full eligibility criteria
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 04 (TRASTUZUMAB AND PERTUZUMAB) OUTLINED BELOW\
- \ When trastuzumab- and pertuzumab-specific inclusion/
- or precautions below differ from those specified in the Master Protocol, the trastuzumab- and pertuzumab-specific criteria will take precedence. Inclusion Criteria: A. Confirmed diagnosis of a malignancy harbouring HER2...
- A HER2 amplification copy number between 5-9 will require an MTB discussion. A HER2 amplification copy number ≥10 will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities...
- Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.
- Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception as in C, above.
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate. All male patients must refrain from donating sperm...
- Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of trastuzumab and pertuzumab, and patients with punctate CNS haemorrhages \<3 mm may be...
- CD4 count ≥350/μL;
- undetectable viral load;
- receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and
- no HIV/ acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Metropolitan Borough of Wirral, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom; Edinburgh, United Kingdom and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.