Actively Recruiting
Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer
Led by Institut Curie · Updated on 2025-03-27
66
Participants Needed
13
Research Sites
261 weeks
Total Duration
On this page
Sponsors
I
Institut Curie
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer (HER2+ MBC) after progression on tucatinib-capecitabine-trastuzumab or capecitabine-related toxicity.
CONDITIONS
Official Title
Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First disease progression under tucatinib-capecitabine-trastuzumab or medical reason preventing use of capecitabine with tucatinib-trastuzumab
- Age over 18 years
- Histologically confirmed HER2-positive breast cancer with tumor tissue available
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Ability to swallow capsules
- Willingness and ability to follow study procedures for the duration of the study
- Measurable disease based on RECIST version 1
- Patients with brain metastases eligible if urgent treatment is not required and certain time periods after brain treatments are met
- Available records of any CNS treatment for lesion classification
- Left ventricular ejection fraction of 50% or higher within 4 weeks before inclusion
- Adequate organ function based on blood counts and liver/kidney tests within 14 days before treatment
- Women of childbearing potential with negative pregnancy test and use of effective contraception; men agreeing to use contraception during and after study
- Health insurance coverage
- Ability to provide signed informed consent
You will not qualify if you...
- Prior treatment with lapatinib within 12 months before study (except short use without progression or severe toxicity)
- Prior use of neratinib, afatinib, or other investigational HER2/EGFR or HER2 tyrosine kinase inhibitors (except uninterrupted tucatinib use)
- Reduced dose tucatinib (<300mg twice daily) in safety run-in phase
- Use of strong CYP3A4 or CYP2C8 inhibitors or inducers shortly before study drug
- Inability to undergo brain MRI
- Leptomeningeal metastases or brain metastases needing immediate treatment or high-dose corticosteroids
- Poorly controlled seizures or neurological progression due to brain metastases
- Unresolved toxicities from prior cancer therapies above grade 1 with some exceptions
- Recent chemotherapy, radiotherapy, biological or investigational therapy within specified timeframes before treatment
- Major surgery within 28 days before inclusion
- Other malignancies needing systemic treatment within 2 years before study
- Use of other cancer treatments or investigational agents concurrently
- Pregnant, lactating, or planning pregnancy
- Serious systemic disorders including active infections, HIV, hepatitis B or C, severe renal impairment, interstitial lung disease, severe dyspnea, liver disease, or significant gastrointestinal conditions
- Significant cardiopulmonary disease including arrhythmia, uncontrolled hypertension, heart failure history, severe dyspnea, hypoxia, QT prolongation, or conditions causing drug-induced QT prolongation
- Recent myocardial infarction or unstable angina within 6 months
- Need for warfarin or coumarin anticoagulants
- Inability to swallow pills or gastrointestinal disease affecting absorption
- Mental or psychiatric conditions preventing informed consent
- Legal protection or deprivation of liberty
- Inability to comply with medical monitoring due to social, geographic, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Centre Jean Perrin
Clermont-Ferrand, Clermont Ferrand, France, 63011
Suspended
2
CHU Amiens Picardie-Site Sud
Amiens, France, 80054
Actively Recruiting
3
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
4
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
5
Centre Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
6
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
7
Institut Du Cancer Montpellier
Montpellier, France, 34298
Suspended
8
Hôpital Privé du Confluent
Nantes, France, 44277
Actively Recruiting
9
Institut Curie
Paris, France, 75005
Actively Recruiting
10
Hopital Saint-Louis Ap-Hp Senopole
Paris, France, 75010
Not Yet Recruiting
11
Centre CARIO-Hôpital Privé des Côtes d'Armor (HPCA)
Plérin, France, 22190
Actively Recruiting
12
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
13
Oncopole Claudius Regaud
Toulouse, France, 31059
Suspended
Research Team
F
Fouzia Azzouz
CONTACT
S
Sandra Nespoulous
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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