| Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor-Negative Breast Cancer. | |
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MedLine Citation:
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PMID: 22827973 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Epidemiologic data support an inverse association between green tea intake and breast cancer risk and numerous experimental studies have demonstrated the anti-tumor effects of its main component, epigallocatechin gallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I-III hormone receptor-negative breast cancer of an oral green tea extract, Polyphenon E (Poly E) 400mg, 600mg, 800mg bid or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose limiting toxicity (DLT, grade≥2). Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400mg, 11 at 600mg, 3 at 800mg). There was 1 DLT at 400mg (grade 3 rectal bleeding), 3 DLTs at 600mg (grade 2 weight gain, grade 3 indigestion and insomnia), and 1 DLT at 800mg (grade 3 liver function abnormality). The DLT rate at 600mg was 27% (3/11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600mg bid. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals. |
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Authors:
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Katherine D Crew; Powel Brown; Heather Greenlee; Therese B Bevers; Banu K Arun; Clifford A Hudis; Heather L McArthur; Jenny Chang; Mothaffar F Rimawi; Lana Vornik; Terri L Cornelison; Antai Wang; Hanina H Hibshoosh; Aqeel Ahmed; Mary Beth Terry; Regina M Santella; Scott M Lippman; Dawn L Hershman |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-7-24 |
Journal Detail:
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Title: Cancer prevention research (Philadelphia, Pa.) Volume: - ISSN: 1940-6215 ISO Abbreviation: - Publication Date: 2012 Jul |
Date Detail:
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Created Date: 2012-7-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101479409 Medline TA: Cancer Prev Res (Phila) Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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1Medicine and Epidemiology, Columbia University. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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