Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal D… (NCT04588545) | Clinical Trial Compass
RecruitingPhase 1/2
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
United States39 participantsStarted 2020-12-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
And/or patients with HER2 positive cells in the cerebral spinal fluid.
* Participants may have concomitant brain metastases
* Cerebrospinal fluid (CSF) sampling is required to document LMD if not documented by MRI. Participants are still eligible CSF is negative but LMD disease is documented on MRI
* Life expectancy greater than 8 weeks
* Consent to pretreatment tumor biopsy or retrieval of archival tissue
* 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%
* KPS \>/= 60
* Patients with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
* There is no limit on prior systemic or IT therapies
* Must be willing to have an Ommaya reservoir placed and a candidate for an Ommaya reservoir placement
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study. Contraception methods should start a minimum of 14 days before the first administra…
What they're measuring
1
Phase 1: Maximum Tolerated Dose (MTD) of Intrathecal (IT) pertuzumab in combination with IT trastuzumab
Timeframe: Up to 12 weeks per dosing cohort
2
Phase 2: Overall Survival (OS)
Timeframe: 1 year after study enrollment
Trial details
NCT IDNCT04588545
SponsorH. Lee Moffitt Cancer Center and Research Institute