OncoMatch/Clinical Trials/NCT04588545
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
Is NCT04588545 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pertuzumab and Trastuzumab for her2-positive breast cancer.
Treatment: Pertuzumab · Trastuzumab — The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (IHC 3+ and/or FISH-positive; IHC 2+ with reflex FISH-positive (ratio ≥2.0))
Confirmation of HER2 positivity. All patients with HER2+ cancers will be allowed to enroll if they have leptomeningeal disease (LMD). Patients may be IHC 3+ and/or FISH-positive. IHC 2+ HER2 patients are eligible with reflex FISH-positive testing with the ratio ≥2.0.
Required: HER2 (ERBB2) amplification (HER2 positive cells in the cerebral spinal fluid)
patients with HER2 positive cells in the cerebral spinal fluid
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: systemic agents (chemotherapy) with CNS penetration (temozolomide, carmustine, lomustine, etoposide, capecitabine, carboplatin, vinorelbine, bevacizumab, irinotecan, topotecan)
Exception: unless they develop or have progressive or persistent leptomeningeal metastases while on these agent(s)
Cannot be on systemic agents (chemotherapy) that have Central Nervous System (CNS) penetration (temozolomide, carmustine, lomustine, etoposide, capecitabine, carboplatin, vinorelbine, bevacizumab, irinotecan, and topotecan) unless they develop or have progressive or persistent leptomeningeal metastases while on these agent(s).
Lab requirements
Blood counts
white blood cells ≥2.5, neutrophils ≥1000, platelets ≥75,000, hemoglobin ≥8
Kidney function
creatinine <1.5 × ULN
Liver function
bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN
Cardiac function
LVEF >50%
Normal renal (creatinine <1.5 × upper limit of normal [ULN]), liver (bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥75,000, hemoglobin ≥8); LVEF >50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Northwestern University · Evanston, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify