| Title |
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 |
| Protocole ID |
HER2CLIMB-05 |
| ClinicalTrials.gov ID |
NCT05132582 |
| Cancer Type(s) |
Breast |
| Phase |
Phase III |
| Stage |
Metastatic |
| Study Type |
Clinical |
| Drug |
Tucatinib ou placebo avec trastuzumab et pertuzumab |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Jean-Pierre Ayoub
|
| Coordinator |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Status |
Recruiting |
| Activation Date |
06-03-2023 |
| Eligibility Criteria |
- Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.
-
Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
- Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression
- 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 brain magnetic resonance imaging (MRI), participants may have any of the following:
- No evidence of brain metastases
- Untreated brain metastases which are asymptomatic 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
|
| Exclusion Criteria |
- Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor 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 MRI of the brain
-
CNS Exclusion - Based on screening brain MRI and clinical assessment
- Symptomatic brain metastasis
- 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
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Groupe d'étude en oncologie du Québec