Phase IB randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon E in women with hormone receptor-negative breast cancer

Cancer Prevention Research

Volumn 5, Issue 9, 2012, Pages 1144-1154

  Crew, Katherine D ^a   Brown, Powel ^c   Greenlee, Heather ^a   Bevers, Therese B ^c   Arun, Banu ^c   Hudis, Clifford ^b   McArthur, Heather L ^b   Chang, Jenny ^d   Rimawi, Mothaffar ^e   Vornik, Lana ^c   Cornelison, Terri L ^f   Wang, Antai ^a   Hibshoosh, Hanina ^a   Ahmed, Aqeel ^a   Terry, Mary Beth ^a   Santella, Regina M ^a   Lippman, Scott M ^c   Hershman, Dawn L ^a  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c UNIVERSITY OF TEXAS   (United States)

^d HOUSTON METHODIST HOSPITAL   (United States)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; POLYPHENON E;

ABDOMINAL PAIN; ADULT; ANEMIA; ARTICLE; BLOOD SAMPLING; BREAST BIOPSY; BREAST CANCER; CONFUSION; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG URINE LEVEL; DYSPNEA; ESTROGEN RECEPTOR AND PROGESTERONE RECEPTOR NEGATIVE BREAST CANCER; FEMALE; FLATULENCE; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HEART PALPITATION; HOT FLUSH; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; HYPERURICEMIA; INDIGESTION; INSOMNIA; MAJOR CLINICAL STUDY; MAMMOGRAPHY; MAXIMUM TOLERATED DOSE; MENSTRUAL IRREGULARITY; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; URINALYSIS; WEIGHT GAIN;

ADULT; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CARCINOMA; CATECHIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE;

EID: 84866145433     PISSN: 19406207     EISSN: 19406215     Source Type: Journal    
DOI: 10.1158/1940-6207.CAPR-12-0117     Document Type: Article

References (50)

1. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998;90:1371-88. (Pubitemid 28439961)
2. Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 2006;295:2727-41.
3. Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, et al. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med 2011;364:2381-91.
4. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. (Pubitemid 40372904)
5. Ogunleye AA, Xue F, Michels KB. Green tea consumption and breast cancer risk or recurrence: a meta-analysis. Breast Cancer Res Treat 2010;119:477-84.
6. Nakachi K, Suemasu K, Suga K, Takeo T, Imai K, Higashi Y. Influence of drinking green tea on breast cancer malignancy among Japanese patients. Jpn J Cancer Res 1998;89:254-61. (Pubitemid 28197289)
7. Inoue M, Tajima K, Mizutani M, Iwata H, Iwase T, Miura S, et al. Regular consumption of green tea and the risk of breast cancer recurrence: follow-up study from the Hospital-based Epidemiologic Research Program at Aichi Cancer Center (HERPACC), Japan. Cancer Lett 2001;167:175-82. (Pubitemid 32706681)
8. Wu AH, Yu MC, Tseng CC, Hankin J, Pike MC. Green tea and risk of breast cancer in Asian Americans. Int J Cancer 2003;106:574-9. (Pubitemid 36966216)
9. Wu AH, Tseng CC, Van Den Berg D, Yu MC. Tea intake, COMT genotype, and breast cancer in Asian-American women. Cancer Res 2003;63:7526-9. (Pubitemid 37413498)
10. Yang CS. Inhibition of carcinogenesis by tea. Nature 1997;389:134-5.
11. Yang CS, Wang X, Lu G, Picinich SC. Cancer prevention by tea: animal studies, molecular mechanisms and human relevance. Nat Rev Cancer 2009;9:429-39.
12. Stuart EC, Scandlyn MJ, Rosengren RJ. Role of epigallocatechin gallate (EGCG) in the treatment of breast and prostate cancer. Life Sci 2006;79:2329-36. (Pubitemid 44772933)
13. Chang PY, Mirsalis J, Riccio ES, Bakke JP, Lee PS, Shimon J, et al. Genotoxicity and toxicity of the potential cancer-preventive agent polyphenon E. Environ Mol Mutagen 2003;41:43-54. (Pubitemid 36159622)
14. Chow HH, Cai Y, Alberts DS, Hakim I, Dorr R, Shahi F, et al. Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and polyphenon E. Cancer Epidemiol Biomarkers Prev 2001;10:53-8. (Pubitemid 32106044)
15. Chow HH, Cai Y, Hakim IA, Crowell JA, Shahi F, Brooks CA, et al. Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallate and polyphenon E in healthy individuals. Clin Cancer Res 2003;9:3312-9. (Pubitemid 37082725)
16. Cheung YK, Chappell R. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics 2000;56:1177-82.
17. Byng JW, Yaffe MJ, Lockwood GA, Little LE, Tritchler DL, Boyd NF. Automated analysis of mammographic densities and breast carcinoma risk. Cancer 1997;80:66-74. (Pubitemid 27270921)
18. Inoue-Choi M, Yuan JM, Yang CS, Van Den Berg DJ, Lee MJ, Gao YT, et al. Genetic association between the COMT genotype and urinary levels of tea polyphenols and their metabolites among daily green tea drinkers. Int J Mol Epidemiol Genet 2010;1:114-23.
19. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
20. Cheung YK, Chappell R. A simple technique to evaluate model sensitivity in the continual reassessment method. Biometrics 2002;58:671-4. (Pubitemid 35001486)
21. Kapetanovic IM, Crowell JA, Krishnaraj R, Zakharov A, Lindeblad M, Lyubimov A. Exposure and toxicity of green tea polyphenols in fasted and non-fasted dogs. Toxicology 2009;260:28-36.
22. Mazzanti G, Menniti-Ippolito F, Moro PA, Cassetti F, Raschetti R, Santuccio C, et al. Hepatotoxicity from green tea: a review of the literature and two unpublished cases. Eur J Clin Pharmacol 2009;65:331-41.
23. Shanafelt TD, Call TG, Zent CS, LaPlant B, Bowen DA, Roos M, et al. Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia. J Clin Oncol 2009;27:3808-14.
24. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. N Engl J Med 1994;330:1029-35.
25. Albanes D, Heinonen OP, Taylor PR, Virtamo J, Edwards BK, Rautalahti M, et al. Alpha-Tocopherol and beta-carotene supplements and lung cancer incidence in the alpha-tocopherol, beta-carotene cancer prevention study: effects of base-line characteristics and study compliance. J Natl Cancer Inst 1996;88:1560-70. (Pubitemid 26374509)
26. Omenn GS, Goodman G, Thornquist M, Grizzle J, Rosenstock L, Barnhart S, et al. The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers. Cancer Res 1994;54 Suppl:2038s-43s. (Pubitemid 24132171)
27. Cole BF, Baron JA, Sandler RS, Haile RW, Ahnen DJ, Bresalier RS, et al. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA 2007;297:2351-9. (Pubitemid 46883748)
28. Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, et al. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA 2011;306:1549-56.
29. Fu H, He J, Mei F, Zhang Q, Hara Y, Ryota S, et al. Lung cancer inhibitory effect of epigallocatechin-3-gallate is dependent on its presence in a complex mixture (polyphenon E). Cancer Prev Res 2009;2:531-7.
30. Lee MJ, Maliakal P, Chen L, Meng X, Bondoc FY, Prabhu S, et al. Pharmacokinetics of tea catechins after ingestion of green tea and (-)-epigallocatechin-3-gallate by humans: formation of different metabolites and individual variability. Cancer Epidemiol Biomarkers Prev 2002;11:1025-32. (Pubitemid 35192653)
31. Cauley JA, Lucas FL, Kuller LH, Stone K, Browner W, Cummings SR. Elevated serum estradiol and testosterone concentrations are associated with a high risk for breast cancer. Study of Osteoporotic Fractures Research Group. Ann Intern Med 1999;130:270-7. (Pubitemid 29091854)
32. Key TJ, Appleby PN, Reeves GK, Roddam AW. Insulin-like growth factor 1 (IGF1), IGF binding protein 3 (IGFBP3), and breast cancer risk: pooled individual data analysis of 17 prospective studies. Lancet Oncol 2010;11:530-42.
33. Maruyama K, Iso H, Ito Y, Watanabe Y, Inaba Y, Tajima K, et al. Associations of food and nutrient intakes with serum IGF-I, IGF-II, IGFBP-3, TGF-b1, total SOD activity and sFas levels among middle-aged Japanese: the Japan Collaborative Cohort study. Asian Pac J Cancer Prev 2009;10 Suppl:7-22.
34. Nagata C, Kabuto M, Shimizu H. Association of coffee, green tea, and caffeine intakes with serum concentrations of estradiol and sex hormone-binding globulin in premenopausal Japanese women. Nutr Cancer 1998;30:21-4. (Pubitemid 28150517)
35. Wu AH, Arakawa K, Stanczyk FZ, Van Den Berg D, Koh WP, Yu MC. Tea and circulating estrogen levels in postmenopausal Chinese women in Singapore. Carcinogenesis 2005;26:976-80. (Pubitemid 41214327)
36. Farabegoli F, Barbi C, Lambertini E, Piva R. (-)-Epigallocatechin-3- gallate downregulates estrogen receptor alpha function in MCF-7 breast carcinoma cells. Cancer Detect Prev 2007;31:499-504. (Pubitemid 350181735)
37. Satoh K, Sakamoto Y, Ogata A, Nagai F, Mikuriya H, Numazawa M, et al. Inhibition of aromatase activity by green tea extract catechins and their endocrinological effects of oral administration in rats. Food Chem Toxicol 2002;40:925-33. (Pubitemid 34626700)
38. Goodin MG, Rosengren RJ. Epigallocatechin gallate modulates CYP450 isoforms in the female Swiss-Webster mouse. Toxicol Sci 2003;76:262-70. (Pubitemid 38035419)
39. Wu AH, Spicer D, Stanczyk FZ, Tseng CC, Yang CS, Pike MC. Effect of 2-month controlled green tea intervention on lipoprotein cholesterol, glucose, and hormone levels in healthy postmenopausal women. Cancer Prev Res 2012;5:393-402.
40. Cuzick J, Warwick J, Pinney E, Duffy SW, Cawthorn S, Howell A, et al. Tamoxifen-induced reduction in mammographic density and breast cancer risk reduction: a nested case-control study. J Natl Cancer Inst 2011;103:744-52.
41. Khan QJ, Kimler BF, Clark J, Metheny T, Zalles CM, Fabian CJ. Ki-67 expression in benign breast ductal cells obtained by random periareolar fine needle aspiration. Cancer Epidemiol Biomarkers Prev 2005;14:786-9. (Pubitemid 40478536)
42. Khan SA, Rogers MA, Khurana KK, Meguid MM, Numann PJ. Estrogen receptor expression in benign breast epithelium and breast cancer risk. J Natl Cancer Inst 1998;90:37-42. (Pubitemid 28078079)
43. Wu AH, Ursin G, Koh WP, Wang R, Yuan JM, Khoo KS, et al. Green tea, soy, and mammographic density in Singapore Chinese women. Cancer Epidemiol Biomarkers Prev 2008;17:3358-65.
44. Shoker BS, Jarvis C, Sibson DR, Walker C, Sloane JP. Oestrogen receptor expression in the normal and pre-cancerous breast. J Pathol 1999;188:237-44. (Pubitemid 29317764)
45. Shaaban AM, Sloane JP, West CR, Foster CS. Breast cancer risk in usual ductal hyperplasia is defined by estrogen receptor-alpha and Ki-67 expression. Am J Pathol 2002;160:597-604. (Pubitemid 34160337)
46. Nguyen MM, Ahmann FR, Nagle RB, Hsu CH, Tangrea JA, Parnes HL, et al. Randomized, double-blind, placebo controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Cancer Prev Res 2012;5:290-8
47. Dawling S, Roodi N, Mernaugh RL, Wang X, Parl FF. Catechol-O- methyltransferase (COMT)-mediated metabolism of catechol estrogens: comparison of wild-type and variant COMT isoforms. Cancer Res 2001;61:6716-22. (Pubitemid 32896493)
48. Stearns V, Gallagher A, Kleer CG, Singh B, Freedman M, Haddad BR, et al. A pilot study to establish a clinical model to perform phase II studies of breast cancer chemopreventive agents inwomenat high risk with biomarkers as surrogate endpoints for activity. Clin Cancer Res 2004;10:8332-40. (Pubitemid 40053394)
49. Malone KE, Begg CB, Haile RW, Borg A, Concannon P, Tellhed L, et al. Population-based study of the risk of second primary contralateral breast cancer associated with carrying a mutation in BRCA1 or BRCA2. J Clin Oncol 2010;28:2404-10.
50. Swain SM, Wilson JW, Mamounas EP, Bryant J, Wickerham DL, Fisher B, et al. Estrogen receptor status of primary breast cancer is predictive of estrogen receptor status of contralateral breast cancer. J Natl Cancer Inst 2004;96:516-23. (Pubitemid 38559575)