Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis

NCT06230055 | Recruiting Phase 4 DMC

• 1 other identifier: CONQUER
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-negative Breast Cancer; Leptomeningeal Metastasis

Outcome Measures

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.

  Six months after the last patient was enrolled

Study Arms (2)

intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy

EXPERIMENTAL

Intrathecal 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). Systematic 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).

Device: Ommaya reservoir; Drug: Systematic chemotherapy; Drug: Intrathecal chemotherapy

systematic chemotherapy

ACTIVE COMPARATOR

Systematic 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).

Drug: Systematic chemotherapy

Interventions

Ommaya reservoir DEVICE

Intrathecal chemotherapy through Ommaya reservoir

intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy

Systematic chemotherapy DRUG

Systematic 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 through Ommaya reservoir in combination with systematic chemotherapy; systematic chemotherapy

Intrathecal chemotherapy DRUG

Intrathecal 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).

intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Failure of standard treatment, or intolerance to standard treatment;
• pial metastasis is present, which is defined as meningeal metastasis confirmed by malignant tumor cells found in cerebrospinal fluid cytology; Or clinical symptoms/signs suggest meningeal metastasis, and brain MRI suggests pia enhancement;
• The function of major organs was good, which was confirmed by the following laboratory tests during the screening period:
• Platelet count ≥80\*10\^9/L
• Hemoglobin ≥8g/L
• Neutrophil count ≥1.5\*10\^9/L
• Serum creatinine ≤1.5\*ULN
• ALT and AST≤ 3\*ULN (if liver metastases are present, ALT and AST≤5\*ULN)
• Serum total bilirubin ≤1.5\*ULN
• International Standardized ratio (INR) and Activated partial thromboplastin time (APTT) ≤1.5\*ULN
• NYHA cardiac function grade ≤II, no obvious abnormality in ECG, or no clinical significance according to the investigators;

You may not qualify if:

• 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;
• There are serious organic diseases or major organ failure, such as decompensated heart and lung failure, which can not tolerate treatment;
• Patients with bleeding tendency;
• Patients who have received organ transplants;
• Patients taking adrenal corticosteroids or immunosuppressants for a long time;
• Intracranial hemorrhage unrelated to tumor disease;
• Patients with central nervous system complications requiring urgent treatment;
• Test group: subjects who could not collect CSF;
• The subject has a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases;
• Active viral hepatitis B (HBsAg positive with HBV DNA≥500 IU/mL) or hepatitis C. Among hepatitis C antibody positive subjects, only those whose polymerase chain reaction showed negative HCV RNA were eligible for enrollment (chronic hepatitis B or chronic hepatitis C patients with stable disease receiving standard antiviral therapy were eligible for enrollment);
• The subject has a serious cardiovascular clinical disease or symptom, including:
• Congestive heart failure

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Central Study Contacts

Jian Zhang

CONTACT

+8664175590; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 29, 2024
• Study Start: January 5, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)