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Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

ConditionsLeptomeningeal MetastasisLeptomeningeal DiseaseHER2-positive Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 the investigator or the sponsor, can confirm in writing the patient's consent;

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 should be performed preferably metastatic site; any estrogen and progesterone (ER/PR) status is allowed;

Disqualifiers

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 substrates should be avoided one week before enrollment and during study treatment;

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 ;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tucatinib Oral Tablet

    Drug

    300 mg, twice daily

  • Capecitabine tablets

    Drug

    1000 mg/m², twice daily on days 1-14 of each 21-day cycle

  • Trastuzumab Injection

    Drug

    Intrathecal by lumbar puncture or Ommaya Reservoir, 150 mg weekly

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Tucatinib + Intrathecal Trastuzumab + CapecitabineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

overall survival rate at 12 months

12-month overall survival will be defined as the proportion of patients alive 12 months after treatment initiation.

Time frame
12 months

Secondary outcomes

1

Clinical neurological symptoms relief

Clinical neurological symptoms relief will be defined as complete or partial diminution of symptoms associated to leptomeningeal metastasis using the neurologic assessment in neuro-oncology (NANO) scale, a standardized questionnaire designed to measure neurological function in oncology. The questionnaire includes 5 domains scored 0-3 (gait, strength, visual fields, language, and level of consciousness) and 4 domains scored 0-2 (ataxia of upper extremities, sensation, facial strength, and behavior). Scores are sum up to a maximum of 23 points with high-scale values representing impaired neurological performances.

Time frame
At baseline, every week during treatment up to 18 months then every 9 weeks up to 42 months
2

Progression free survival (PFS)

The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

Time frame
From inclusion to disease progression or death, up to 42 months
3

Overall survival (OS)

The overall survival (OS) is the length of time from inclusion in the study that patients are still alive.

Time frame
From inclusion to death from any cause; up to 42 months
4

Quality of life questionnaire - Core 30 (QLQ-C30)

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Time frame
At baseline, every 3 weeks during treatment up to 18 months then every 9 weeks up to 42 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Seagen Inc.

Collaborator

Source ClinicalTrials.gov
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