Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) (HER2CLIMB-05)
Interventional
Phase 3
Seagen Inc. (Voir sur ClinicalTrials)
mars 2022
octobre 2027
16 octobre 2024
This study is being done to see if tucatinib works better than placebo when given with
other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill
that looks the same as tucatinib but has no medicine in it. This study will also test
what side effects happen when participants take this combination of drugs. A side effect
is anything a drug does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally
advanced) and cannot be removed (unresectable) or has spread through the body
(metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will
be assigned randomly to a group. This is a blinded study, so patients and their doctors
will not know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to
treat this type of cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:18 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie - 22190 - Cotes d'Armor - Other - France | Contact (sur clinicalTrials) | ||||
| Center Georges Francois Leclerc - 21000 - Dijon - Other - France | Contact (sur clinicalTrials) | ||||
| Centre de Cancerologie du Grand Montpellier - 34070 - Montpellier - Other - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte contre le Cancer - Francois Baclesse - 14076 - Caen Cedex 5 - Other - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne - 06189 - Nice Cedex 2 - Other - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte contre le Cancer (CLCC) - Centre Oscar Lambret - 59000 - Lille - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35042 - Rennes - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer - 76038 - Rouen - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz - 25000 - Besancon Cedex - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren - 87042 - Limoges Cedex - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - Other - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes - 69008 - Lyon cedex 08 - Other - France | Contact (sur clinicalTrials) | ||||
| Hopitaux Civils de Lyon - 69310 - Pierre Benite - Other - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - Other - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de lOuest - Site Rene Gauducheau - 44800 - Saint Herblain cedex - Other - France | Contact (sur clinicalTrials) | ||||
| Institut de cancerologie Strasbourg Europe - 67033 - Strasbourg - Other - France | Contact (sur clinicalTrials) | ||||
| Institut Regional du Cancer de Montpellier - 34298 - Montpellier - Other - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut du Cancer Avignon Provence - 84000 - Avignon - Other - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of
Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior
to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC
and concurrent positive by ISH).
- Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment
free from any trastuzumab and pertuzumab received in the early breast cancer
setting for advanced HER2+ disease.
- Have received 4-8 cycles of pre-study induction therapy including only trastuzumab,
pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast
cancer prior to study enrollment. Participants are eligible provided they are
without evidence of disease progression following completion of induction therapy.
- Known hormone receptor status (per local guidelines; may be hormone receptor
positive [HR+] or negative [HR-])
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance
imaging (MRI), participants may have any of the following:
- No evidence of brain metastases
- Untreated brain metastases which are asymptomatic not needing immediate local
treatment and, if identified on prior brain imaging, without evidence of
progression since starting first-line induction therapy with trastuzumab,
pertuzumab, and taxane
- Previously treated brain metastases which are asymptomatic
- Brain metastases previously treated with local therapy must not have
progressed since treatment
- Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of
Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior
to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC
and concurrent positive by ISH).
- Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment
free from any trastuzumab and pertuzumab received in the early breast cancer
setting for advanced HER2+ disease.
- Have received 4-8 cycles of pre-study induction therapy including only trastuzumab,
pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast
cancer prior to study enrollment. Participants are eligible provided they are
without evidence of disease progression following completion of induction therapy.
- Known hormone receptor status (per local guidelines; may be hormone receptor
positive [HR+] or negative [HR-])
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance
imaging (MRI), participants may have any of the following:
- No evidence of brain metastases
- Untreated brain metastases which are asymptomatic not needing immediate local
treatment and, if identified on prior brain imaging, without evidence of
progression since starting first-line induction therapy with trastuzumab,
pertuzumab, and taxane
- Previously treated brain metastases which are asymptomatic
- Brain metastases previously treated with local therapy must not have
progressed since treatment
- Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal
growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib,
and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months
have elapsed since last neratinib dose prior to start of study drug)
- Unable to undergo contrast-enhanced MRI of the brain
- CNS Exclusion - Based on screening brain MRI and clinical assessment
- Symptomatic brain metastasis after CNS-directed local therapy
- Progression of brain metastases since starting first line trastuzumab,
pertuzumab, and taxane
- Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of
dexamethasone (or equivalent)
- Any untreated brain lesion in an anatomic site which may pose risk to
participant
- Known or suspected leptomeningeal disease (LMD)
- Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms