OCTS-07 TRIAL IN PROGRESS: PHASE II STUDY OF RADIATION THERAPY FOLLOWED BY INTRATHECAL TRASTUZUMAB/PERTUZUMAB IN THE MANAGEMENT OF HER2+ BREAST LEPTOMENINGEAL DISEASE Article Swipe
YOU?
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· 2024
· Open Access
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· DOI: https://doi.org/10.1093/noajnl/vdae090.092
BACKGROUND HER2+ leptomeningeal disease (LMD) has a poor prognosis with a high unmet clinical need. A previous phase I/II study revealed intrathecal (IT) trastuzumab to be well tolerated with improved overall survival (OS) compared to historical controls in HER2+ breast LMD. Radiotherapy can improve the flow of IT therapy through the cerebrospinal fluid (CSF) and provide symptomatic relief. The monoclonal antibody pertuzumab is used in conjunction with trastuzumab in the systemic management of HER2+ breast cancer. The phase I portion of the current study used a modified toxicity probability interval-2 (mTPI-2) design to determine 80 mg IT pertuzumab as the recommended phase II dose with a fixed dose of 80 mg IT trastuzumab. METHODS The study is designed as a prospective, single-arm, nonrandomized, open-label, phase II trial of radiation therapy followed by IT trastuzumab/pertuzumab in the management of HER2+ breast LMD. HER2+ LMD patients identified by magnetic resonance imaging (MRI) and/or CSF cytology, ≥18, with a life expectancy > 8 weeks are eligible. Treatment is initiated with radiotherapy, whole brain radiotherapy and/or focal brain/spine radiation followed by IT trastuzumab/pertuzumab. The primary objective of the phase II portion is to evaluate OS following IT trastuzumab/pertuzumab. Secondary objectives involve evaluating the response rate (leptomeningeal and parenchymal), and progression free survival (leptomeningeal and parenchymal). A single-arm two-stage trial is designed using the Restricted-Kwak-and-Jung’s Method. The primary endpoint is one-year OS. An interim analysis will be performed after 20 patients are enrolled with plans to enroll an additional 10 patients if criteria are met. This study is open with 14 patients enrolled at the time of submission. Clinical trial information: NCT04588545.
Related Topics
- Type
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- Language
- en
- Landing Page
- https://doi.org/10.1093/noajnl/vdae090.092
- https://academic.oup.com/noa/article-pdf/6/Supplement_1/i28/58723324/vdae090.092.pdf
- OA Status
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- Cited By
- 2
- Related Works
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- OpenAlex ID
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Raw OpenAlex JSON
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https://openalex.org/W4401305071Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1093/noajnl/vdae090.092Digital Object Identifier
- Title
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OCTS-07 TRIAL IN PROGRESS: PHASE II STUDY OF RADIATION THERAPY FOLLOWED BY INTRATHECAL TRASTUZUMAB/PERTUZUMAB IN THE MANAGEMENT OF HER2+ BREAST LEPTOMENINGEAL DISEASEWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-08-01Full publication date if available
- Authors
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Kamran A. Ahmed, Priya Kumthekar, Youngchul Kim, Michelle DeJesus, Yolanda Piña, Daniel Oliver, Brittany Evernden, John A. Arrington, Michael A. Vogelbaum, Marilin Rosa, Hatem Soliman, Michael Yu, Hyo S. Han, Peter ForsythList of authors in order
- Landing page
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https://doi.org/10.1093/noajnl/vdae090.092Publisher landing page
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https://academic.oup.com/noa/article-pdf/6/Supplement_1/i28/58723324/vdae090.092.pdfDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://academic.oup.com/noa/article-pdf/6/Supplement_1/i28/58723324/vdae090.092.pdfDirect OA link when available
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Pertuzumab, Medicine, Trastuzumab, Clinical endpoint, Oncology, Radiation therapy, Metastatic breast cancer, Internal medicine, Breast cancer, Clinical trial, CancerTop concepts (fields/topics) attached by OpenAlex
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2Total citation count in OpenAlex
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2025: 2Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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