Could a breast cancer drug combo treat rare tumors?

NCT ID NCT05786716

Disease control Sponsor: Cancer Research UK Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests two drugs, trastuzumab and pertuzumab, already approved for breast cancer, in people with rare cancers that have a specific genetic change called HER2 amplification or mutation. About 30 adults and children with various rare or hard-to-treat cancers will receive the drugs every three weeks. The goal is to see if the combination shrinks tumors or stops them from growing for at least 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: trastuzumab (Herceptin) and pertuzumab (Perjeta)
What this could lead to: If successful, this could expand access to an existing breast cancer drug combination for people with rare HER2-driven cancers, offering a new treatment option.
What could go wrong: This is an early-to-mid-stage trial with only 30 participants. The drugs may not work as well in other cancer types, and side effects like heart problems or infusion reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/exclusion criteria 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 amplification, or an appropriate activating mutation as defined by the MTB, using an analytically validated next-generation sequencing method. • 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 (such as multiple gene amplifications) that require MTB discussion. B. Age 12 years or above. C. Women of childbearing potential are eligible provided that they meet the following criteria: Have a negative serum or urine pregnancy test before enrolment and; Agree to use one form of effective birth control method such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal): II. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable) III. intrauterine device (IUD) IV. intrauterine hormone-releasing system (IUS) V. bilateral tubal occlusion VI. vasectomised partner VII. sexual abstinence VIII. male or female condom with or without spermicide IX. cap, diaphragm or sponge with spermicide Effective from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later). D. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later): * 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 for the same period. E. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken. F. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. G. PAEDIATRIC PATIENTS (\<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. Exclusion Criteria: A. Diagnosis of HER2-positive early or metastatic breast cancer. B. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within seven months following their last dose of trastuzumab or pertuzumab (whichever is later). C. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. D. Known hypersensitivity to trastuzumab or pertuzumab, murine proteins, or to any of the excipients. E. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during trastuzumab and pertuzumab treatment or within six months after the final dose of trastuzumab and pertuzumab. F. 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. • 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 considered. G. 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. H. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial. I. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of trastuzumab and pertuzumab, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met: * 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.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm gallbladder neoplasm hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lung neoplasm neoplasm ovarian cancer ovarian neoplasm pancreatic neoplasm prostate cancer salivary gland cancer skin neoplasm tumor of salivary gland urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal neoplasms Gallbladder neoplasms Haematological malignancy Lung neoplasm Ovarian neoplasms Pancreatic neoplasm Prostatic neoplasm Salivary gland neoplasm Skin neoplasm Solid tumour Urinary bladder neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

27 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Addenbrooke's Hospital
RECRUITING

Cambridge, CB2 OQQ, United Kingdom
Alder Hey Hospital
RECRUITING

Liverpool, L14 5AB, United Kingdom
Belfast City Hospital
RECRUITING

Belfast, BT9 7AB, United Kingdom
Birmingham Children's Hospital
NOT_YET_RECRUITING

Birmingham, United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING

Bristol, BS2 8ED, United Kingdom
Bristol Royal Hospital for Children
RECRUITING

Bristol, BS2 8BJ, United Kingdom
Cardiff Children's Hospital
NOT_YET_RECRUITING

Cardiff, CF14 4XW, United Kingdom
Churchill Hospital
RECRUITING

Oxford, OX3 7LE, United Kingdom
Clatterbridge Cancer Centre
RECRUITING

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Freeman Hospital
RECRUITING

Newcastle, NE7 7DN, United Kingdom
Great North Children's Hospital
RECRUITING

Newcastle, NE1 4LP, United Kingdom
Great Ormond Street Hospital
RECRUITING

London, WC1N 3JH, United Kingdom
Guy's Hospital
RECRUITING

London, SE1 9RT, United Kingdom
John Radcliffe Hospital
RECRUITING

Oxford, OX3 9DU, United Kingdom
Leicester Royal Infirmary
RECRUITING

Leicester, LE1 5WW, United Kingdom
Royal Hospital for Children Glasgow
RECRUITING

Glasgow, G51 4TF, United Kingdom
Royal Manchester Children's Hospital
NOT_YET_RECRUITING

Manchester, M13 9WL, United Kingdom
Sheffield's Children's Hospital
RECRUITING

Sheffield, S10 2TH, United Kingdom
Southampton General Hospital
RECRUITING

Southampton, SO16 6YD, United Kingdom
The Beatson Hospital
RECRUITING

Glasgow, G12 OYN, United Kingdom
The Christie Hospital
RECRUITING

Manchester, M20 4BX, United Kingdom
The Royal Marsden Hospital
RECRUITING

Sutton, SM2 5PT, United Kingdom
University College London Hospital
RECRUITING

London, NW1 2BU, United Kingdom
University Hospital Birmingham
RECRUITING

Birmingham, B15 2TT, United Kingdom
Velindre Cancer Centre
RECRUITING

Cardiff, CF14 2TL, United Kingdom
Western General Hospital
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Weston Park Hospital
RECRUITING

Sheffield, S10 2SJ, United Kingdom

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