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New treatment option for Leptomeningeal Metastasis
Official title Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
ClinicalTrials.gov ID: NCT05800275
What this study is testing
What is Tucatinib Oral Tablet?
Tucatinib Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for leptomeningeal metastasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their...
- Patients ≥18 years old;
- Histologically confirmed metastatic breast cancer;
- Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or...
- Proven leptomeningeal progression defined by linear leptomeningeal metastases on magnetic resonance imaging (MRI) or the presence of breast cancer...
You likely can't join if
- Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days...
- Previous treatment with Tucatinib or Capecitabine;
- Severe leukopenia, neutropenia, or thrombocytopena, severe hepatic impairment, severe renal impairment (creatinine clearance below 30mL/min)
- Recent or concomitant treatment with brivudine ;
- Any antiplatelet or curative anticoagulant treatment for blood coagulation disorders;
- Severe pre-existing cerebrovascular dysfunction or pathology such as stroke and intra-cerebral hematoma or uncontrolled intracerebral hypertension...
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from...
- Patients ≥18 years old;
- Histologically confirmed metastatic breast cancer;
- Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology; Note: HER2 testing...
- Proven leptomeningeal progression defined by linear leptomeningeal metastases on magnetic resonance imaging (MRI) or the presence of breast cancer cells in CSF (obtained within 28 days before inclusion );
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2;
- Life expectancy ≥2 months;
- Stable dose of steroids for at least 5 days prior to registration;
- If symptomatic brain or leptomeningeal metastasis, local treatment (surgery, radiation therapy) is allowed until 2 weeks before inclusion but should have been completed no more than 8 weeks before inclusion and with no...
- Adequate hematological function within 14 days before inclusion: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL;
- Adequate liver function within 14 days before inclusion: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); AST and ALT ≤2.5 ULN (≤5 ULN in the presence of liver metastases);
- Normal renal function within 14 days before inclusion: estimated creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula;
- Adequate cardiac function:
- 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- QT/QTc interval ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kaliemia
- Left ventricular ejection fraction (LVEF) ≥55%
- No history of Torsades de Pointes or other symptomatic QTc abnormality
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National cancer institute-Common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or 0 to baseline...
- Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion;
- Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment/therapy. Hormonal contraceptives such as...
- Patients affiliated to the social security system (or equivalent);
- Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up.
What rules you out
- Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A...
- Previous treatment with Tucatinib or Capecitabine;
- Severe leukopenia, neutropenia, or thrombocytopena, severe hepatic impairment, severe renal impairment (creatinine clearance below 30mL/min)
- Recent or concomitant treatment with brivudine ;
- Any antiplatelet or curative anticoagulant treatment for blood coagulation disorders;
- Severe pre-existing cerebrovascular dysfunction or pathology such as stroke and intra-cerebral hematoma or uncontrolled intracerebral hypertension induced by brain metastasis;
- Ventriculoperitoneal or atrial shunt, except if the valve is equipped with an on-off device and that the patient's condition allows for to remain in the off position for 6 hours after each injection of trastuzumab;
- Known history of testing positive for HIV or known acquired immunodeficiency syndrome;
- Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease;
- Uncontrolled hypertension;
- Uncontrolled infection;
- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy;
- Pregnant or breast-feeding women;
- Known prior severe hypersensitivity to tucatinib or compounds chemically or/and biologically similar or any component in its formulation;
- Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients in its formulation;
- Known prior severe hypersensitivity to capecitabine or to any of the excipients or fluorouracil;
- Known complete dihydropyrimidine dehydrogenase (DPD) deficiency (if applicable);
- Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications;
- Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least...
- Person deprived of their liberty or under protective custody or guardianship;
- Participation in another therapeutic trial within the 30 days prior to treatment initiation;
- Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment, are not eligible. Patients unwilling or unable to comply with trial obligations for geographic...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Lyon, France
- Montpellier, France
- Nice, France
- Reims, France
- Rouen, France
- Strasbourg, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Caen, France; Clermont-Ferrand, France; Dijon, France; Lyon, France; Montpellier, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.