Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 years or above;
Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
The physical status score of the Eastern Oncology Consortium (ECOG) was ≤3;
HER2-metastatic breast cancer confirmed histologically or cytologically (HER2- is defined as either a standard immunohistochemical (IHC) test result of 0 or 1+, or an IHC test result of 2+ and a negative ISH test result);
Disqualifiers
Pregnant or lactating women;
Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Both primary cancers are expected to benefit from this study. Investigators have identified the primary tumor source of the metastases);
Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
Trial design
Design model
Parallel
Treatments tested in this trial
Ommaya reservoir
DeviceIntrathecal chemotherapy through Ommaya reservoir
Systematic chemotherapy
DrugSystematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt).
Intrathecal chemotherapy
DrugIntrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center).
Treatment groups
37 Participants
are divided into 2 treatment groupsGroup A: intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapyExperimental treatment 3 interventions
Group B: systematic chemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neural progression-free survival (NPFS)
Clinical outcome of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systematic chemotherapy Upon Her-2 negative breast cancer with leptomeningeal metastasis: Neural progression-free survival (NPFS) calculated from the randomized date until first observation of meningeal metastasis progression (LM-PD) or death (whichever occurs earlier). Neural progression, according to the RANO-LM criteria, is defined as: neurological examination/worsening of symptoms, or CSF cytological progression, or imaging progression.
Time frame
Six months after the last patient was enrolledSponsors and contacts
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Source ClinicalTrials.gov