NBQ72S for leptomeningeal breast cancer

A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S in Breast Cancer Patients With Leptomeningeal Metastases, With or Without Brain Parenchymal Metastases

This trial will try NBQ72S given by IV every 28 days to see if it helps people whose breast cancer has spread to the leptomeninges.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Nantong Bencao Quadriga Medical Technology Co. Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06810804 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label Phase IIa study gives patients with breast cancer leptomeningeal metastases intravenous NBQ72S every 28 days until disease progression, unacceptable toxicity, or withdrawal. Eligible patients must have leptomeningeal disease confirmed by MRI or cerebrospinal fluid cytology and a Karnofsky Performance Status of at least 60, with adequate blood and kidney function. Patients who show clinical benefit despite radiographic progression may be allowed to continue treatment at the investigator's discretion. After treatment ends, participants undergo safety follow-up and long-term survival follow-up until death or loss to follow-up.

Who should consider this trial

Good fit: Adults with histologically confirmed breast cancer and leptomeningeal metastasis (with or without brain parenchymal metastases), KPS ≥60, and adequate bone marrow and renal function are ideal candidates.

Not a fit: Patients with poor performance status (KPS <60), significant organ dysfunction, or without imaging or CSF confirmation of leptomeningeal disease are unlikely to benefit.

Why it matters

Potential benefit: If successful, NBQ72S could slow or control leptomeningeal disease and potentially extend survival with an acceptable safety profile.

How similar studies have performed: There are limited prior data for NBQ72S specifically, and while some systemic and intrathecal treatments have shown occasional benefit in leptomeningeal disease, durable responses remain uncommon.

Eligibility criteria

Inclusion Criteria:

* The patient must have histological evidence confirming the diagnosis of breast cancer with leptomeningeal metastasis: a. Breast cancer must be diagnosed through biopsy from either the primary or metastatic sites; b. Leptomeningeal metastasis (with or without brain parenchymal metastases) must be confirmed by imaging examinations(MRI), or by positive or suspicious cerebrospinal fluid cytology; c. There is no restriction on the duration of prior systemic therapy for the primary tumor.
* The patient's Karnofsky Performance Status (KPS) must be ≥60.
* The patient must have adequate bone marrow function, including:

  1. Absolute neutrophil count (ANC) ≥1,500/mm³ or ≥1.5 x 10⁹/L;
  2. Platelet count ≥100,000/mm³ or ≥100 x 10⁹/L;
  3. Hemoglobin ≥9 g/dL;
* The patient must have adequate renal function, including:

  a. Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥50 mL/min. Note: In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately;
* The patient must have adequate hepatic function, including:

  1. Total serum bilirubin ≤1.5 x ULN; if the tumor involves the liver, or if the patient has a history of Gilbert's syndrome, total bilirubin must be \<3 x ULN;
  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; if the tumor involves the liver, these values must be ≤5.0 x ULN;
* Females of childbearing potential and males with fertile partners must agree to use effective contraception during the study and for 7 months following the last dose of study treatment;

Exclusion Criteria:

* Patients with any other active malignancies unrelated to the primary tumor, except for those with basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma that have been adequately treated.
* Patients who are intolerant to any substance in the investigational product, including sulfobutylether-β-cyclodextrin, mefenamic acid, bendamustine, chloramphenicol, or any nitrogen mustard chemotherapy agents, or who have experienced a severe (Grade ≥3) allergic or hypersensitivity reaction to these substances.
* Patients who have received a live vaccine or experimental drug within 30 days prior to Cycle 1, Day 1 (C1D1).
* Pregnant or breastfeeding patients.
* Any other conditions that may affect the patient's eligibility for this study in the judgment of the investigator

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Binghe Xu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Raylene Liu

Conditions Breast Cancer