Actively Recruiting
Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
Led by UNICANCER · Updated on 2025-11-18
30
Participants Needed
11
Research Sites
180 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.
CONDITIONS
Official Title
Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed informed consent or a trusted person has provided consent if patient is unable
- Age 18 years or older
- Histologically confirmed metastatic breast cancer
- HER2-positive breast cancer confirmed by ISH, IHC, or FISH testing
- Proven leptomeningeal disease shown by MRI or cancer cells in cerebrospinal fluid within 28 days
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Life expectancy of at least 2 months
- Stable steroid dose for at least 5 days before registration
- Local brain or leptomeningeal treatments completed 2 to 8 weeks before inclusion if symptomatic
- Adequate blood counts within 14 days before inclusion
- Adequate liver function within 14 days before inclusion
- Normal kidney function with creatinine clearance of 60 mL/min or higher within 14 days
- Adequate heart function with normal or non-significant ECG changes, QT/QTc intervals within limits, and LVEF of 55% or higher
- Recovery from prior treatment side effects to grade 1 or baseline except alopecia
- Negative pregnancy test within 14 days for women of childbearing potential
- Agreement to use effective contraception during and 7 months after treatment for women and men
- Affiliation with social security or equivalent
- Willingness and ability to follow the protocol, visits, treatment, tests, and follow-up
You will not qualify if you...
- Use of strong CYP2C8 inhibitors or CYP3A4/CYP2C8 inducers shortly before study start
- Previous treatment with tucatinib or capecitabine
- Severe low white blood cells or platelets, severe liver or kidney impairment
- Recent or ongoing treatment with brivudine
- Use of antiplatelet or anticoagulant therapy for coagulation disorders
- Severe cerebrovascular issues like stroke or uncontrolled brain pressure
- Ventriculoperitoneal or atrial shunt unless valve can be turned off for 6 hours after trastuzumab
- Known HIV infection or AIDS
- Chronic liver disease including hepatitis B or C carriers
- Uncontrolled high blood pressure or infection
- Severe breathing difficulty at rest or oxygen requirement
- Pregnant or breastfeeding women
- Severe allergy to tucatinib, trastuzumab, capecitabine, or related compounds
- Complete deficiency of DPD enzyme if applicable
- Unable to swallow tablets or severe gastrointestinal disease
- Other cancers within 5 years except certain skin or cervical cancers
- Being deprived of liberty or under legal guardianship
- Participation in another therapeutic trial within 30 days
- Any other disease or condition requiring hospitalization or incompatible with study treatment
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Institut Bergonié
Bordeaux, France, 33000
Withdrawn
2
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
4
Centre Georges-François Leclerc
Dijon, France, 21000
Actively Recruiting
5
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
6
Institut régional du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
8
Institut Jean Godinot
Reims, France, 51100
Actively Recruiting
9
Centre Henri Becquerel
Rouen, France, 7600
Actively Recruiting
10
Institut de cancérologie Strasbourg Europe - ICANS
Strasbourg, France, 67200
Actively Recruiting
11
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
T
Telma ROQUE, PhD
CONTACT
J
Jérôme LEMONNIER, PhD
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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