Study of Tucatinib, Trastuzumab, and Pertuzumab for Patients with Advanced or Metastatic HER2+ Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as HER2-positive breast cancer, which is a form of cancer that has high levels of a protein called HER2. The study is investigating the effectiveness of a treatment combination that includes the medications Tucatinib, Trastuzumab, and Pertuzumab. These medications are used as maintenance therapy, which means they are given to help keep the cancer from coming back or getting worse after initial treatment. The trial will compare the effects of this combination with a placebo, which is a substance with no active medication.

The purpose of the study is to see how well the treatment works in preventing the cancer from progressing, which means getting worse or spreading. Participants in the study will receive either the combination of medications or a placebo, and their health will be monitored over time. The study will involve regular check-ups and assessments to track the progress of the disease and any side effects of the treatment. The trial aims to provide more information on how effective this treatment is in managing advanced or metastatic HER2-positive breast cancer.

Throughout the study, participants will undergo various tests and evaluations, including imaging tests like MRI to check for any changes in the brain, as some patients may have brain metastases, which are cancer cells that have spread to the brain. The study will also look at the overall survival of participants, which is the length of time they live after starting the study, and their quality of life during the treatment. The trial is expected to continue for several years to gather enough data to determine the effectiveness of the treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including the type of breast cancer and previous treatments received.

The study focuses on individuals with advanced or metastatic HER2+ breast cancer.

2 randomization

Participants are randomly assigned to receive either the study medication or a placebo.

This process ensures that the study results are unbiased and reliable.

3 treatment administration

The treatment involves a combination of medications: trastuzumab, pertuzumab, and tucatinib or a placebo.

Trastuzumab and pertuzumab are administered as a solution for injection.

Tucatinib is provided in the form of film-coated tablets, available in 50 mg and 150 mg dosages, taken orally.

4 treatment schedule

The treatment is administered as maintenance therapy following initial induction therapy.

Participants receive the medications according to a schedule determined by the study protocol.

5 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the participant’s response to the treatment.

Assessments include imaging tests and evaluations based on specific criteria to measure disease progression.

6 end of study participation

Participation in the study continues until disease progression or other criteria for discontinuation are met.

The study aims to compare progression-free survival and overall survival between the treatment groups.

Who Can Join the Study?

  • The patient must have a type of breast cancer called HER2+, which is confirmed by specific tests. These tests look for certain proteins in the cancer cells.
  • The cancer must be unresectable (cannot be removed by surgery) and either locally advanced or has spread to other parts of the body (metastatic).
  • If the cancer has come back after previous treatment, the patient must have been free from certain treatments (trastuzumab and pertuzumab) for at least 6 months.
  • The patient must have received 4-8 cycles of specific pre-study treatments (trastuzumab, pertuzumab, and taxane) for advanced breast cancer and must not show signs of the cancer getting worse after these treatments.
  • The patient must know their hormone receptor status, which means whether the cancer cells have certain hormone receptors or not.
  • The patient must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Regarding the brain, based on a special brain scan (MRI), the patient may have no brain metastases, untreated brain metastases that are not causing symptoms, or previously treated brain metastases that are not causing symptoms and have not gotten worse.
  • The patient must be within certain age ranges, which are typically adult age groups.
  • Both male and female patients can participate.
  • The study may include patients who are considered part of a vulnerable population.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not HER2+ breast cancer cannot participate. HER2+ breast cancer is a type of breast cancer that has a protein called HER2 on the surface of its cells.
  • Patients who have had surgery to remove the cancer cannot participate. Unresectable means the cancer cannot be removed by surgery.
  • Patients who have cancer that has spread to other parts of the body, known as metastatic cancer, cannot participate.
  • Patients who have cancer that is only in one place and has not spread, known as locally-advanced cancer, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or who have other health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have certain medical conditions or are taking medications that could affect the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Medizinische Hochschule Hannover Hanover Germany
Kuopio University Hospital Kuopio Finland
Centre Jean Perrin Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
NH Hospital a.s. Horovice Czechia
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Metaxa Cancer Center Hospital Of Piraeus Piraeus Greece
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Universita’ Degli Studi Di Ferrara Ferrara Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital San Pedro De Alcantara Caceres Spain
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. Coimbra Portugal
Humanitas Istituto Clinico Catanese S.p.A. Misterbianco Italy
Centre De Cancerologue Du Grand Montpellier Montpellier France
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Hospital Universitario Virgen De Las Nieves Granada Spain
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Vaasa Central Hospital Vaasa Finland
Centre Henri Becquerel Rouen France
General University Hospital Of Larissa Larissa Greece
Hôpital Avicenne Bobigny France
Virgen del Rocío University Hospital Sevilla Spain
Alexandra Hospital Athens Greece
St. Elisabeth Krankenhaus GmbH Cologne Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Champalimaud Clinical Centre Lisbon Portugal
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universita’ Politecnica Delle Marche Ancona Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
General University Hospital Of Patras Patras Greece
Azienda USL Toscana Centro Prato Italy
Hopital Prive Des Cotes D’armor Plerin France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Pirkanmaan hyvinvointialue Tampere Finland
Hospital Universitario De Canarias La Laguna Spain
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Servei De Salut De Les Illes Balears Palma Spain
Institut Sainte Catherine Avignon France
Fakultni Thomayerova nemocnice Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Cmpqwgnui Uvtgtpsvmrgaef Sqoawggsz Woluwe-Saint-Lambert Belgium
Ivdfbxig Rrvvahoc Dl Cxfnzk Df Mskxxmvljec Montpellier France
Clawdt Liqb Btlzgu Lyon France
Uxcwhvxdkt Mrhrgpl Cpjuql Hepbgoqvfcgzlujje Hamburg Germany
Oiflwiqwnhxhvo Lqng Ghyz Linz Austria
Uvkqxsnpztbizrtwaaanm Ayvsqxqg Augsburg Germany
Wiptcunphoe Wyotgiuddsibhbdmdrai Cmblwyg Ocplzpajd I Tilkejdgdivvf Ic Mrnlvrxcfza W Ljzxq Lodz Poland
Ifhi Gttcj Filothei Greece
Oqhetaygjx Pe Djy Mt Hsllpze Schwaz Austria
Axzlnsy Uvn Tfmqmni nxur orknv Leghorn Italy
Fcbvyeim ngadupoim Moeqa a Hntaswl Prague Czechia
Bjjlpagr Ufjffpruvz Hdudjjzc Cwcrlv Besançon France
Hfetguze Uopcuknnez Ckgtwlm Hdzgobtn Helsinki Finland
Uryjowmtftyduldfuezoy Mqffsnbi Auf Munster Germany
Nmnvffxt Icpduddh Ovefmjyqt Iai Mcfav Suketyfyoqwtgvkfiskiojwunukx Isnnercb Biipppzs Cracow Poland
Uqhshnnibryfoqoyofpvo Wrvvfxvhl Asp Wuerzburg Germany
Arbzkva Uuqve Schdqovfo Lfswvo Du Bfforjg Bologna Italy
Uljmocnkgjiboe Cptqjdu Klfftowdd Gdansk Poland
Hloryndi Dy Lo Sftwt Cqgc I Szsh Pyu Barcelona Spain
Axwkhzg Ojirnqkbdsj Uqomjtromertg Pwqst Parma Italy
Ijndlrqh Cqgqja Dqzfjvzaiojeozrhh L'hospitalet De Llobregat Spain
Hyscnaup Visc dfasdtpq Barcelona Spain
Cqpoiv Ojafn Ljvobga Lille France
Iuogsxjr Cfwbr Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.12.2021
Belgium Belgium
Not recruiting
01.12.2021
Czechia Czechia
Not recruiting
01.12.2021
Finland Finland
Not recruiting
01.12.2021
France France
Not recruiting
01.12.2021
Germany Germany
Not recruiting
01.12.2021
Greece Greece
Not recruiting
01.12.2021
Italy Italy
Not recruiting
01.12.2021
Poland Poland
Not recruiting
01.12.2021
Portugal Portugal
Not recruiting
01.12.2021
Spain Spain
Not recruiting
01.12.2021
The Netherlands The Netherlands
Not recruiting
01.12.2021

Trial locations

Tucatinib is a medication used in this trial to treat metastatic HER2-positive breast cancer. It works by blocking certain proteins that help cancer cells grow. In this study, it is being tested to see if it can help stop the cancer from getting worse when used with other treatments.

Trastuzumab is a therapy used to treat HER2-positive breast cancer. It targets the HER2 protein on cancer cells, helping to slow or stop their growth. In this trial, it is used in combination with other medications to see if it can improve outcomes for patients.

Pertuzumab is another medication used to treat HER2-positive breast cancer. It works by attaching to the HER2 protein and preventing cancer cells from growing. In this study, it is combined with other treatments to evaluate its effectiveness in maintaining cancer control.

Investigated diseases:

Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. In its unresectable form, the cancer cannot be removed completely through surgery. When it is locally advanced, the cancer has spread beyond the breast to nearby tissues or lymph nodes but not to distant organs. In the metastatic stage, the cancer has spread to other parts of the body, such as the bones, liver, or lungs. The disease progresses as cancer cells continue to grow and spread, often leading to the involvement of multiple organs. The progression can vary significantly among individuals, influenced by factors like the cancer’s biology and the patient’s overall health.

Trial ID:
2023-503826-37-00
Protocol code:
SGNTUC-028
NCT ID:
NCT05132582
Trial Phase:
Therapeutic confirmatory (Phase III)

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