Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 2-Hydroxy-1,2,3-propanetricarboxylate-(Z)-2-[4-(1,2-diphyl-1-butenyl)phenoxy]-N,Ndimethyl ethanamine
Molecular Formula: C26H29NO•C6H8O7
CAS Number: 54965-24-1
For women with ductal carcinoma in situ (DCIS) and women at high risk for breast cancer: serious and life-threatening events associated with tamoxifen in the risk reduction setting include uterine malignancies, stroke, and pulmonary embolism.a Incidence rates for these events have been estimated from the NSABP P-1 trial (median length of follow-up 6.9 years).a
Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1000 women-years of 2.2 for tamoxifen versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1000 women-years of 0.17 for tamoxifen versus 0 for placebo).
For stroke, the incidence rate per 1000 women-years was 1.43 for tamoxifen versus 1 for placebo.a
For pulmonary embolism, the incidence rate per 1000 women-years was 0.75 for tamoxifen versus 0.25 for placebo.a
Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer.a
The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.a
A nonsteroidal estrogen agonist-antagonist; an antineoplastic agent.128
Uses for Tamoxifen Citrate
An adjuvant to surgery and radiation therapy for the treatment of breast cancer in women with negative axillary lymph nodes and in postmenopausal women with positive axillary lymph nodes.110 121 128 130 133 136 194 195 196 198 204 205 253 254 258 Also reduces the occurrence of contralateral breast cancer in these women.128 253 254 258
Reduction of risk of invasive breast cancer in patients with DCIS following surgery and radiation therapy.a
Palliative treatment of metastatic breast cancer in men and women.128 An alternative to ovarian ablative therapy (oopherectomy or radiation) in premenopausal women.128 133 158 159 160 161 162 163 164 165 166 167 168 169 183
Has been used to reduce the frequency of vaginal bleeding episodes and to reduce the rate of increase in bone age in girls with Albright’s syndrome (McCune-Albright syndrome†) and precocious puberty.a
Long-term effects not established.a
Tamoxifen Citrate Dosage and Administration
Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.
Administered orally as a single daily dose or in divided doses; dosages exceeding 20 mg daily should be given in divided doses (morning and evening).128
Initiate therapy during menstruation when used to reduce the incidence of breast cancer in sexually active women.a In women with menstrual irregularity, a negative β-human chorionic gonadotropin test immediately prior to therapy is sufficient.a
Available as tamoxifen citrate; dosage expressed in terms of tamoxifen.128
Ductal Carcinoma in SituOral
20 mg daily for 5 years.a
Metastatic Breast CancerOral
20–40 mg daily.128
Reduction in the Incidence of Breast Cancer in Women at High RiskOral
Cautions for Tamoxifen Citrate
Known hypersensitivity to tamoxifen or any ingredient in the formulation.128
When used in women with DCIS and women at high risk for breast cancer, history of DVT or pulmonary embolism.a
Effects on the Uterus
Increased incidence of uterine malignancies, sometimes fatal, reported.128 330 Most uterine malignancies have been classified as adenocarcinoma of the endometrium; rare uterine sarcomas also reported.128 330 (See Boxed Warning.) Gynecologic symptoms (i.e., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, pelvic pain or pressure) should be promptly evaluated.128 163 183
Endometrial changes, including hyperplasias and polyps, endometriosis and uterine fibroids reported.128 180 258 259 274 Ovarian cysts reported in a small number of premenopausal women with advanced breast cancer.128
Increased incidence of thromboembolic events, including DVT128 293 and pulmonary embolism; 269 270 293 stroke also reported.128 269 277 293 Some cases of stroke and pulmonary emboli have been fatal.128 (See Boxed Warning.) Concomitant use with chemotherapy may increase incidence of these events.128
Liver cancer reported.128
Changes in AST, ALT, bilirubin and/or alkaline phosphatase concentrations reported; severe hepatic abnormalities including fatty changes in the liver, cholestasis, hepatitis, and hepatic necrosis (some fatal) reported rarely.128
Visual disturbances, decrement in color vision perception, corneal changes, cataracts, optic neuritis, retinal vein thrombosis, intraretinal crystals, posterior subcapsular opacities, and/or retinopathy reported.128 190 191 192 193 258 268 326
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm.128 If inadvertently used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard, including possible long-term risk of a diethylstilbestrol-like syndrome.128
Category D.128 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Safety and efficacy in girls 2–10 years of age with Albright’s syndrome and precocious puberty not studied beyond 1 year; long-term effects not established and continued monitoring recommended.a (See Special Populations under Pharmacokinetics.)
No substantial differences in safety and efficacy relative to younger adults.a
Common Adverse Effects
Hot flashes, vaginal discharge, menstrual irregularities, weight loss.128
Interactions for Tamoxifen Citrate
A substrate of CYP3A, 2C9, 2D6.a
Effect of tamoxifen on drugs that require mixed function oxidases for activation unknown.a
Increased risk of thromboembolic events.128
Decreased plasma tamoxifen and N-desmethyltamoxifen concentrations128
Anticoagulants (e.g., warfarin)
When used in women with DCIS or at high risk for breast cancer, concomitant use contraindicateda
Increased plasma tamoxifen and N-desmethyltamoxifen concentrations128
Competitively inhibited formation of N-desmethyltamoxifen in vitroa
Clinicial importance unknowna
Competitively inhibited formation of N-desmethyltamoxifen in vitroa
Clinicial importance unknowna
Competitively inhibited formation of N-desmethyltamoxifen in vitroa
Clinicial importance unknowna
Decreased plasma letrozole concentrationsa
Decreased plasma N-desmethyltamoxifen concentrations but did not reduce plasma tamoxifen concentrationsa
Competitively inhibited formation of N-desmethyltamoxifen in vitroa
Clinicial importance unknowna
Decreased plasma tamoxifen concentrations128
Clinical importance unknown128
Decreased plasma tamoxifen and N-desmethyltamoxifen concentrationsa
Tamoxifen Citrate Pharmacokinetics
Not fully characterized.128
Not known whether tamoxifen is distributed into milk.128
Rapidly and extensively metabolized.26 28 140 142 143 144 145 146 148 149 150 151 The major metabolite, N-desmethyltamoxifen,128 140 143 144 145 146 148 150 151 has biologic activity similar to that of the parent drug.128
Excreted principally in feces as polar conjugates.128
Clearance higher in female children 2–10 years of age than in women; exposure to N-desmethyltamoxifen in these pediatric patients similar to adults.a
Well-closed, light-resistant containers 20–25°C.128
Acts as an estrogen antagonist on breast tissue and in the CNS and as an estrogen agonist on endometrium, bone, and lipids.311
Acts as an estrogen agonist on the uterus and exhibits proliferative and tumor-promoting effects on the endometrium.311
Advice to Patients
Importance of receiving routine gynecologic care and of immediately informing clinician if any new breast lumps or abnormal gynecologic symptoms, including abnormal vaginal bleeding, change in vaginal discharge, menstrual irregularities, or pelvic pain/pressure occur.128 163 183
Importance of immediately informing clinician of unexplained shortness of breath or leg swelling/tenderness.128
Importance of periodic monitoring, including liver function test monitoring and blood counts.128
Advise patients at high risk of breast cancer that tamoxifen may decrease the incidence of breast cancer, but may not eliminate the risk of the disease.128
Importance of women informing clinicians immediately if they are or plan to become pregnant; importance of avoiding pregnancy during therapy;119 128 243 importance of using effective nonhormonal contraception while receiving tamoxifen and for 2 months after discontinuing the drug.a Necessity of advising pregnant patients of the risk to the fetus.128
Importance of reading the medication guide; the guide is for women using tamoxifen to lower their risk of breast cancer or with DCIS.128
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.128
Importance of women informing clinicians if they are or plan to breast-feed.128
Importance of informing patients of other important precautionary information.128 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
10 mg (of tamoxifen)*
Tamoxifen Citrate Tablets
Aegis, Andrx, Barr, Mylan, Roxane, Teva
20 mg (of tamoxifen)*
Tamoxifen Citrate Tablets
Aegis, Andrx, Barr, Mylan, Roxane, Teva
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Nolvadex 20MG Tablets (ASTRAZENECA): 30/$120.99 or 60/$239.98
Tamoxifen Citrate 10MG Tablets (MYLAN): 30/$14.99 or 60/$20.98
Tamoxifen Citrate 20MG Tablets (TEVA PHARMACEUTICALS USA): 30/$61.99 or 90/$165.98
AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
26. Fromson JM, Sharp DS. The selective uptake of tamoxifen by human uterine tissue. J Obstet Gynaecol Br Comm. 1974; 81:321-3.
28. Fromson JM, Pearson S. The metabolism of tamoxifen (I.C.I. 46,474). Part II: in female patients. Xenobiotica. 1973; 3:711-4. [PubMed 4783632]
100. Nolvadex Adjuvant Trial Organisation. Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer: interim analysis at four years. Lancet. 1983; 1:257-61. [IDIS 164603] [PubMed 6130291]
101. Nolvadex Adjuvant Trial Organisation. Improved survival amongst patients treated with adjuvant tamoxifen after mastectomy for early breast cancer. Lancet. 1983; 2:450.
102. Ribeiro G, Palmer MK. Adjuvant tamoxifen for operable carcinoma of the breast: report of clinical trial by the Christie Hospital and Holt Radium Institute. BMJ. 1983; 286:827-30. [IDIS 168605] [PubMed 6403101]
103. Brinkley D. Adjuvant questions. BMJ. 1984; 288:1709-10. [PubMed 6428507]
104. Patterson JS, Battersby LA, Bach BK. Use of tamoxifen in advanced male breast cancer. Cancer Treat Rep. 1980; 64:801-4. [PubMed 7427964]
105. Becher R, Höffken K, Pape H et al. Tamoxifen treatment before orchiectomy in advanced breast cancer in men. N Engl J Med. 1981; 305:169-70. [IDIS 133415] [PubMed 7242589]
106. Hortobagyi GN, Distefano A, Legha SS et al. Hormonal therapy with tamoxifen in male breast cancer. Cancer Treat Rep. 1979; 63:539-41. [IDIS 112371] [PubMed 221118]
107. Stathopoulos GP, Karvountzis GG, Yiotis J. Tamoxifen in carcinoid syndrome. N Engl J Med. 1981; 305:52. [IDIS 133352] [PubMed 7231519]
108. Myers CF, Ershler WB, Tannenbaum MA et al. Tamoxifen and carcinoid tumor. Ann Intern Med. 1982; 96:383. [IDIS 146199] [PubMed 7059114]
109. Moertel CG, Engstrom PF, Schutt AJ. Tamoxifen therapy for metastatic carcinoid tumor: a negative study. Ann Intern Med. 1984; 100:531-2. [IDIS 183832] [PubMed 6200021]
110. Nolvadex Adjuvant Trial Organisation. Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer: analysis at six years. Lancet. 1985; 1:836-40. [IDIS 199145] [PubMed 2858709]
111. Rose C, Thorpe SM, Andersen KW et al. Beneficial effect of adjuvant tamoxifen therapy in primary breast cancer patients with high oestrogen receptor values. Lancet. 1985; 1:16-9. [PubMed 2856949]
112. National Institutes of Health Office of Medical Applications of Research. Consensus conference: adjuvant chemotherapy for breast cancer. JAMA. 1985; 254:3461-3. [IDIS 207936] [PubMed 4068189]
113. Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984; 1:1256-60. [IDIS 186376] [PubMed 6144974]
114. Fisher B, Fisher ER, Redmond C. A brief overview of findings from NSABP trials of adjuvant therapy. Recent Results Cancer Res. 1984; 96:55-65. [PubMed 6101262]
115. Hubay CA, Gordon NH, Crowe JP et al. Antiestrogen-cytotoxic chemotherapy and Bacillus Calmette-Guerin vaccination in stage II breast cancer: seventy-two-month follow-up. Surgery. 1984; 96:61-72. [PubMed 6740497]
116. Cummings FJ, Gray R, Davis TE et al. Adjuvant tamoxifen treatment of elderly women with Stage II breast cancer: a double-blind comparison with placebo. Ann Intern Med. 1985; 103:324-9. [IDIS 205815] [PubMed 3896085]
117. Gau T (Stuart Pharmaceuticals, Wilmington, DE): Personal communication; 1986 Jan 13.
118. Kaiser-Kupfer MI, Lippman ME. Tamoxifen retinopathy. Cancer Treat Rep. 1978; 62:315-20. [PubMed 647693]
119. Diver JMJ, Jackson IM, Fitzgerald JD. Tamoxifen and non-malignant indications. Lancet. 1986; 1:733. [IDIS 213703] [PubMed 2870236]
120. Kaiser-Kupfer MI, Kupfer C, Rodrigues MM. Tamoxifen retinopathy: a clinicopathologic report. Ophthalmology. 1981; 88:89-93. [PubMed 7243233]
121. Report from the Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh. Adjuvant tamoxifen in the management of operable breast cancer: the Scottish trial. Lancet. 1987; 2:171-5. [IDIS 233071] [PubMed 2885637]
122. Fisher B, Brown A, Wolmark N et al. Prolonging tamoxifen therapy for primary breast cancer: findings from the National Surgical Adjuvant Breast and Bowel Project Clinical Trial. Ann Intern Med. 1987; 106:649-54. [IDIS 229430] [PubMed 3551710]
123. Tormey DC. Long-term adjuvant therapy with tamoxifen in breast cancer: how long is long? Ann Intern Med. 1987; 106:762-4. Editorial.
124. Zielinski CC, Kubista E, Salzer H et al. Adjuvant chemotherapy combined with tamoxifen in postmenopausal patients with stage II breast cancer. Lancet. 1986; 2:1164. [IDIS 223328] [PubMed 2877314]
125. Fentiman IS, Caleffi M, Brame E et al. Double-blind controlled trial of tamoxifen therapy for mastalgia. Lancet. 1986; 1:287-8. [IDIS 211071] [PubMed 2868162]
126. Fentiman IS. Tamoxifen and mastalgia: an emerging indication. Drugs. 1986; 32:477-80. [IDIS 223766] [PubMed 3539572]
127. Fisher B, Redmond C, Brown A et al. Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer. J Clin Oncol. 1983; 1:227-41. [PubMed 6366135]
128. Zeneca Pharmaceuticals. Nolvadex (tamoxifen citrate) prescribing information. Wilmington, DE; 1998 Oct 28.
129. Legha SS. Tamoxifen in the treatment of breast cancer. Ann Intern Med. 1988; 109:219-28. [IDIS 244745] [PubMed 3291659]
130. National Cancer Institute. Clinical alert on breast cancer. Bethesda, MD: National Cancer Institute; 1988 May 18.
131. Bradbeer JW, Kyngdon J. Primary treatment of breast cancer in elderly women with tamoxifen. Clin Oncol. 1983; 9:31-4. [PubMed 6851305]
132. Taylor SG IV, Gelman RS, Falkson G et al. Combination chemotherapy compared to tamoxifen as initial therapy for stage IV breast cancer in elderly women. Ann Intern Med. 1986; 104:455-61. [IDIS 213853] [PubMed 3513684]
133. Glick JH. Meeting highlights: adjuvant therapy for breast cancer. J Natl Cancer Inst. 1988; 80:471-5. [PubMed 3367387]
134. Delozier T, Julien JP, Juret P et al. Adjuvant tamoxifen in postmenopausal breast cancer: preliminary results of a randomized trial. Breast Cancer Res Treat. 1986; 7:105-10. [PubMed 3521767]
135. Fisher B, Redmond C, Brown A et al. Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer: 5-year results from the National Surgical Adjuvant Breast and Bowel Project Trial. J Clin Oncol. 1986; 4:459-71. [PubMed 2856857]
136. Early Breast Cancer Trialists’ Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer: an overview of 61 randomized trials among 28,896 women. N Engl J Med. 1988; 319:1681-92. [IDIS 248808] [PubMed 3205265]
137. Fabian C, Sternson L, Barnett M. Clinical pharmacology of tamoxifen in patients with breast cancer: comparison of traditional and loading dose schedules. Cancer Treat Rep. 1980; 64:765-73. [PubMed 7427961]
138. Adam HK, Gay MA, Moore RH. Measurement of tamoxifen in serum by thin-layer densitometry. J Endocrinol. 1980; 84:35-42. [PubMed 7359080]
139. Adam HK, Patterson JS, Kemp JV. Studies on the metabolism and pharmacokinetics of tamoxifen in normal volunteers. Cancer Treat Rep. 1980; 64:761-4. [PubMed 7427960]
140. McVie JG, Simonetti GPC, Stevenson D et al. The bioavailability of Tamoplex(tamoxifen). Part 1: a pilot study. Methods Find Exp Clin Pharmacol. 1986; 8:505-12. [PubMed 3747644]
141. Wilkinson P, Ribeiro G, Adam H et al. Clinical pharmacology of tamoxifen and N-desmethyltamoxifen in patients with advanced breast cancer. Cancer Chemother Pharmacol. 1980; 5:109-11. [PubMed 7471314]
142. Fromson JM, Pearson S, Bramah S. The metabolism of tamoxifen (I.C.I. 46,474). Part I: in laboratory animals. Xenobiotica. 1973; 3:693-709. [PubMed 4361333]
143. Milano G, Etienne MC, Frenay M et al. Optimised analysis of tamoxifen and its main metabolites in the plasma and cytosol of mammary tumours. Br J Cancer. 1987; 55:509-12. [PubMed 3606944]
144. Daniel P, Gaskell SJ, Bishop H et al. Determination of tamoxifen and biologically active metabolites in human breast tumours and plasma. Eur J Cancer Clin Oncol. 1981; 17:1183-9. [PubMed 7199465]
145. Jordan VC. Metabolites of tamoxifen in animals and man: identification, pharmacology, and significance. Breast Cancer Res Treat. 1982; 2:123-38. [PubMed 6184101]
146. Soininen K, Kleimola T, Elomaa I et al. The steady-state pharmacokinetics of tamoxifen and its metabolites in breast cancer patients. J Int Med Res. 1986; 14:162-5. [PubMed 3522312]
147. Ribeiro GG, Wilkinson PM. A clinical assessment of loading dose tamoxifen for advanced breast carcinoma. Clin Oncol. 1984; 10:363-7. [PubMed 6509818]
148. Adam HK, Douglas EJ, Kemp JV. The metabolism of tamoxifen in humans. Biochem Pharmacol. 1979; 27:145-7.
149. Bain RR, Jordan VC. Identification of a new metabolite of tamoxifen in patient serum during breast cancer therapy. Biochem Pharmacol. 1983; 32:373-5. [PubMed 6870963]
150. Jordan VC, Bain RR, Brown RR et al. Determination and pharmacology of a new hydroxylated metabolite of tamoxifen observed in patient sera during therapy for advanced breast cancer. Cancer Res. 1983; 43:1446-50. [IDIS 165659] [PubMed 6825112]
151. Murphy C, Fotsis T, Pantzar P et al. Analysis of tamoxifen and its metabolites in human plasma by gas chromatography-mass spectrometry (GC-MS) using selected ion monitoring (SIM). J Steroid Biochem. 1987; 26:547-55. [PubMed 3586671]
152. Kemp JV, Adam HK, Wakeling AE et al. Identification and biological activity of tamoxifen and metabolites in human serum. Biochem Pharmacol. 1983; 32:2045-52. [PubMed 6870933]
153. Jordan VC, Collins MM, Rowsby L et al. A monohydroxylated metabolite of tamoxifen with potent antioestrogenic activity. J Endocrinol. 1977; 75:305-16. [PubMed 591813]
154. Wakeling AE, Slater SR. Estrogen-receptor binding and biologic activity of tamoxifen and its metabolites. Cancer Treat Rep. 1980; 64:741-4. [PubMed 7427959]
155. Fabian C, Tilzer L, Sternson L. Comparative binding affinities of tamoxifen, 4-hydroxytamoxifen, and desmethyltamoxifen for estrogen receptors isolated from human breast carcinoma: correlation with blood levels in patients with metastatic breast cancer. Biopharm Drug Dispos. 1981; 2:381-90. [IDIS 143191] [PubMed 7317574]
156. Borgna JL, Rochefort H. Hydroxylated metabolites of tamoxifen are formed in vivo and bound to estrogen receptor in target tissues. J Biol Chem. 1981; 256:859-68. [PubMed 7451477]
157. Coezy E, Borgna JL, Rochefort H. Tamoxifen and metabolites in MCF, cells: correlation between binding to estrogen receptor and inhibition of cell growth. Cancer Res. 1982; 42:317-23. [PubMed 7053859]
158. Pritchard KI, Thomson DB, Myers RE et al. Tamoxifen therapy in premenopausal patients with metastatic breast cancer. Cancer Treat Rep. 1980; 64:787-96. [PubMed 7427962]
159. Manni A, Pearson OH. Antiestrogen-induced remissions in premenopausal women with stage IV breast cancer: effects on ovarian function. Cancer Treat Rep. 1980; 64:779-85. [PubMed 6775808]
160. Sawka CA, Pritchard KI, Paterson AH et al. Role and mechanism of action of tamoxifen in premenopausal women with metastatic breast carcinoma. Cancer Res. 1986; 46:3152-6. [IDIS 217168] [PubMed 3084082]
161. Ingle JN, Krook JE, Green SJ et al. Randomized trial of bilateral oophorectomy versus tamoxifen in premenopausal women with metastatic breast cancer. J Clin Oncol. 1986; 4:178-85. [PubMed 3511184]
162. Buchanan RB, Blamey RW, Durrant KR et al. A randomized comparison of tamoxifen with surgical oophorectomy in premenopausal patients with advanced breast cancer. J Clin Oncol. 1986; 4:1326-30. [PubMed 3528402]
163. Legha SS. Tamoxifen in the treatment of breast cancer. Ann Intern Med. 1988; 109:219-28. [IDIS 244745] [PubMed 3291659]
164. Hoogstraten B, Fletcher WS, Gad-el-Mawla N et al. Tamoxifen and oophorectomy in the treatment of recurrent breast cancer. A Southwest Oncology Group study. Cancer Res. 1982; 42:4788-91. [IDIS 159551] [PubMed 7127314]
165. Yoshida M, Murai H, Miura S. Tamoxifen therapy for premenopausal and postmenopausal Japanese females with advanced breast cancer. Jpn J Clin Oncol. 1982; 12:57-63.
166. Margreiter R, Wiegele J. Tamoxifen (Nolvadex) for premenopausal patients with advanced breast cancer. Breast Cancer Res Treat. 1984; 4:45-8. [PubMed 6365211]
167. Planting AS, Alexieva-Figusch J, Blonk-VdWijst J et al. Tamoxifen therapy in premenopausal women with metastatic breast cancer. Cancer Treat Res. 1985; 69:363-8.
168. Wada T, Koyama H, Terasawa T. Effect of tamoxifen in premenopausal Japanese women with advanced breast cancer. Cancer Treat Rep. 1981; 65:728-9. [IDIS 137005] [PubMed 7248991]
169. Hoogstraten B, Gad-el-Mawla N, Maloney TR et al. Combined modality therapy for first recurrence of breast cancer. A Southwest Oncology Group study. Cancer. 1984; 54:2248-56. [IDIS 193333] [PubMed 6488144]
170. Lodwick R, McConkey B, Brown AM. Life threatening interaction between tamoxifen and warfarin. BMJ. 1987; 295:1141. [IDIS 235136] [PubMed 3120919]
171. Tenni P, Lalich DL, Byrne MJ. Life threatening interaction between tamoxifen and warfarin. BMJ. 1989; 298:93. [IDIS 249683] [PubMed 2493305]
172. Ritchie LD, Grant SMT. Tamoxifen–Warfarin interaction: the Aberdeen hospitals drug file. BMJ. 1989; 298:1253.
173. Fornander T, Rutquist LE, Cedermark B et al. Adjuvant tamoxifen in early breast cancer: occurrence of new primary cancers. Lancet. 1989; 1:117-20. [IDIS 249801] [PubMed 2563046]
174. Hardell L. Tamoxifen as risk factor for carcinoma of corpus uteri. Lancet. 1988; 2:563. [IDIS 245548] [PubMed 2900934]
175. Killackey MA, Hakes TB, Pierce VK. Endometrial adenocarcinoma in breast cancer patients receiving antiestrogens. Cancer Treat Rep. 1985; 69:237-8. [IDIS 196903] [PubMed 3971394]
176. Jordan VC. Tamoxifen and endometrial cancer. Lancet. 1989; 1:733-4. [IDIS 254039] [PubMed 2564550]
177. Gottardis MM, Robinson SP, Satyaswaroop PG et al. Contrasting actions of tamoxifen on endometrial and breast tumor growth in the athymic mouse. Cancer Res. 1988; 48:812-5. [PubMed 3338079]
178. Neven P, De Muylder X, Van Belle Y et al. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:375. [IDIS 250800] [PubMed 2563519]
179. Stewart HJ, Knight GM. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:375-6. [PubMed 18446929]
180. Cano A, Matallin P, Legua V et al. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:376. [PubMed 18446930]
181. Boccardo F, Bruzzi P, Rubagotti A et al. Estrogen-like action of tamoxifen on vaginal epithelium in breast cancer patients. Oncology. 1981; 38:281-5. [PubMed 7266969]
182. Boccardo F, Guarneri D, Rubagotti A et al. Endocrine effects of tamoxifen in postmenopausal breast cancer patients. Tumori. 1984; 70:61-8. [PubMed 6538707]
183. Buckley MMT, Goa KL. Tamoxifen: a reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic use. Drugs. 1989; 37:451-90. [IDIS 257967] [PubMed 2661195]
184. Cuzick J, Baum M. Tamoxifen and contralateral breast cancer. Lancet. 1985; 2:282. [IDIS 203072] [PubMed 2862460]
185. Brun LD, Gagne C, Rousseau C et al. Severe lipemia induced by tamoxifen. Cancer. 1986; 57:2123-6. [IDIS 216127] [PubMed 3697911]
186. Noguchi M, Taniya T, Tajiri K et al. Fatal hyperlipaemia in a case of metastatic breast cancer treated by tamoxifen. Br J Surg. 1987; 74:586-7. [PubMed 3620865]
187. Taniya T, Noguchi M, Tajiri K et al. [A case report of hyperlipemia with giant fatty liver during adjuvant endocrine therapy by tamoxifen]. Gan No Rinsho. 1987; 33:300-4. [PubMed 3108557]
188. Rossner S, Wallgren A. Serum lipoproteins and proteins after breast cancer surgery and effects of tamoxifen. Atherosclerosis. 1984; 52:339-46. [PubMed 6497936]
189. McKeown CA, Swartz M, Blom J et al. Tamoxifen retinopathy. Br J Ophthalmol. 1981; 65:177-9. [PubMed 7225310]
190. Vinding T, Nielsen NV. Retinopathy caused by treatment with tamoxifen in low dosage. Acta Ophthalmol. 1983; 61:45-50.
191. Griffiths MF. Tamoxifen retinopathy at low dosage. Am J Ophthalmol. 1987; 104:185-6. [IDIS 232920] [PubMed 3039846]
192. Ashford AR, Donev I, Tiwari RP et al. Reversible ocular toxicity related to tamoxifen therapy. Cancer. 1988; 61:33-5. [IDIS 237645] [PubMed 3334951]
193. Pugesgaard T, Von Eyben FE. Bilateral optic neuritis evolved during tamoxifen treatment. Cancer. 1986; 58:383-6. [IDIS 218074] [PubMed 3719532]
194. National Institutes of Health Office of Medical Applications of Research. Consensus conference: treatment of early-stage breast cancer. JAMA. 1991; 265:391-5. [PubMed 1984541]
195. Fisher B, Redmond C, Wickerham L et al. Systemic therapy in patients with node-negative breast cancer: a commentary based on two national surgical adjuvant breast and bowel project (NSABP) clinical trials. Ann Intern Med. 1989; 111:703-12. [IDIS 260416] [PubMed 2679288]
196. Fisher B, Costantino J, Redmond C et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989; 320:479-84. [IDIS 308825] [PubMed 2644532]
197. Rosner D, Lane WW. One-third of node-negative breast cancer patients are highly curable by surgery alone, without need for adjuvant systemic therapy. Proc Annu Meet Am Soc Clin Oncol. 1990; 9:A63.
198. Redmond CK, Fisher B, Costantino J et al. Treatment of stage I breast cancer: the NSABP experience. Horm Res. 1989; 32(Suppl 1):175-80. [PubMed 2613203]
199. Hillner BE, Smith TJ. Efficacy and cost effectiveness of adjuvant chemotherapy in women with node-negative breast cancer. N Engl J Med. 1991; 324:160-8. [IDIS 276489] [PubMed 1898533]
200. Anon. Adjuvant tamoxifen in early breast cancer. Lancet. 1987; 2:191-2. [PubMed 2885643]
201. McGuire WL. Adjuvant therapy of node-negative breast cancer. N Engl J Med. 1989; 320:525-7. [PubMed 2915655]
202. DeVita VT Jr. Breast cancer therapy: exercising all our options. N Engl J Med. 1989; 320:527-9. [PubMed 2915656]
203. Wolmark N. 1989: The year of adjuvant therapy in node-negative breast cancer. Cancer: Princ Pract Oncol Updates. 1989; 3:1-10.
204. Anon. Tamoxifen for node-negative breast cancer. FDA Drug Bull. 1990; 20:5.
205. Bianco AR, De Placido S, Gallo C et al. Adjuvant therapy with tamoxifen in operable breast cancer. Lancet. 1988; 2:1095-9. [IDIS 247823] [PubMed 2903322]
206. McGuire WL. Adjuvant therapy of node-negative breast cancer: another point of view. J Natl Cancer Inst. 1988; 80:1075-6. [PubMed 3411619]
207. Pritchard KI. Systemic adjuvant therapy for node-negative breast cancer: proven or premature? Ann Intern Med. 1989; 111:1-4. Editorial.
208. Fisher B, Redmond C, Dimitrov NV et al. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med. 1989; 320:473-8. [IDIS 251186] [PubMed 2644531]
209. The Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. N Engl J Med. 1989; 320:491-6. [IDIS 251188] [PubMed 2644533]
210. Mansour EG, Gray R, Shatila AH et al. Efficacy of adjuvant chemotherapy in high-risk node-negative breast cancer. N Engl J Med. 1989; 320:485-90. [IDIS 251187] [PubMed 2915651]
211. Carter CL, Allen C, Henson DE. Relation of tumor size, lymph node status, and survival in 24,740 breast cancer cases. Cancer. 1989; 63:181-7. [PubMed 2910416]
212. Drago F, Arditi M, Rebora A. Tamoxifen and purpuric vasculitis. Ann Intern Med. 1990; 112:965-6. [IDIS 267345] [PubMed 2140253]
213. Fernando IN, Tobias JS. Priapism in patient on tamoxifen. Lancet. 1989; 1:436. [IDIS 251885] [PubMed 2563809]
214. Larsen W, Fellowes G, Rickman LS. Life-threatening hypercalcemia and tamoxifen. Am J Med. 1990; 88:440-2. [IDIS 265545] [PubMed 2327431]
215. Rea D, Poole C, Gray R. Adjuvant tamoxifen: how long before we know how long? BMJ. 1998; 316:1518-9.
216. Stone R. NIH fends off critics of tamoxifen study. Science. 1992; 258:734. [PubMed 1439776]
217. Andersson M, Storm HH, Mouridsen HT. Carcinogenic effects of adjuvant tamoxifen treatment and radiotherapy for early breast cancer. Acta Oncol. 1992; 31:259-63. [PubMed 1622643]
218. Jordan VC. The role of tamoxifen in the treatment and prevention of breast cancer. Curr Probl Cancer. 1992; 16:129-76. [PubMed 1582240]
219. Powles TJ, Hardy JR, Ashley SE et al. A pilot trial to evaluate the acute toxicity and feasibility of tamoxifen for prevention of breast cancer. Br J Cancer. 1989; 60:126-31. [PubMed 2679843]
220. Powles TJ, Tillyer CR, Jones AL et al. Prevention of breast cancer with tamoxifen—an update on the Royal Marsden Hospital pilot programme. Eur J Cancer. 1990; 26:680-4. [PubMed 2144154]
221. Costa A, Jordan VC. Meeting report: long-term antihormonal therapy for breast cancer. Eur J Cancer. 1991; 27:1479-81. [PubMed 1835865]
222. Blackburn AM, Amiel SA, Millis RR et al. Tamoxifen and liver damage. BMJ. 1984; 289:288. [IDIS 188987] [PubMed 6430441]
223. Nand S. Gordon LI, Brestan E et al. Benign hepatic cyst in a patient on antiestrogen therapy for metastatic breast cancer. Cancer. 1982; 50:1882-3. [IDIS 160401] [PubMed 7116312]
224. Anon. Tamoxifen breast cancer prevention trial supporters are “voting with their feet,” NCI tells hearing; NCI has improved controls over informed consent forms. FDC Rep. Oct 26, 1992:5-6.
225. Hardell L. Tamoxifen as a risk factor for enndometrial cancer. Cancer. 1990; 66:1661. [IDIS 273431] [PubMed 2208019]
226. Jaiyesimi IA, Buzdar AU, Sahin AA et al. Carcinoma of the male breast. Ann Intern Med. 1992; 117:771-7. [PubMed 1416579]
227. Ribeiro G, Swindell R. Adjuvant tamoxifen for male breast cancer (MBC). Br J Cancer. 1992; 65:252-4. [PubMed 1739625]
228. Digenis AG, Ross CB, Morrison JG et al. Carcinoma of the male breast: a review of 41 cases. South Med J. 1990; 83:1162-7. [PubMed 1699287]
229. Borgen PI. Male breast cancer. Semin Surg Oncol. 1991; 7:314-9. [PubMed 1775819]
230. Donegan WL. Cancer of the breast in men. Ca Cancer J Clin. 1991; 41:339-54. [PubMed 1933534]
231. Deacock SJ, Ohri SK. A case of synchronous bilateral separate primary male breast carcinomas. BJCP. 1991; 45:152-4.
232. Tirelli U, Tumolol S, Talamini R et al. Tamoxifen before and after orchiectomy in advanced male breast cancer. Cancer Treat Rep. 1982; 66:1882-3. [IDIS 160767] [PubMed 7127330]
233. Aisner J, Ross DD, Wiernik PH. Tamoxifen in advanced male breast cancer. Arch Intern Med. 1979; 139:480-1. [IDIS 133597] [PubMed 435005]
234. Ching CK, Smith PG, Long RG. Tamoxifen-associated hepatocellular damage and agranulocytosis. Lancet. 1992; 339:940. [IDIS 294064] [PubMed 1348345]
235. Abele R, Alberto P. Tamoxifen before orchiectomy for breast cancer in men. N Engl J Med. 1981; 305:1091-2. [IDIS 138688] [PubMed 7278926]
236. Tateishi M, Toda T, Minamisono Y et al. A 94 year old male stage IV breast cancer patient showing complete remission under tamoxifen treatment after operation. J Surg Oncol. 1992; 51:71-3. [PubMed 1518297]
237. Kinne DW. Management of male breast cancer. Oncology. 1991; 5:45-7. [PubMed 1829945]
238. Bezwoda WR, Hesdorffer C, Dansey R et al. Breast cancer in men: clinical features, hormone receptor status, and response to therapy. Cancer. 1987; 60:1337-40. [IDIS 234410] [PubMed 3621116]
239. Zeneca Pharmaceuticals Group, Wilmington, DE: Personal communication.
240. Neven P, De Muylder X, Van Belle Y et al. Hysteroscopic follow-up during tamoxifen treatment. Eur J Obstet Gynecol Reprod Biol. 1990; 35:235-8. [PubMed 2335258]
241. Clark S. Prophylactic tamoxifen. Lancet. 1993; 342:168.
242. Costa A. Tamoxifen trial in healthy women at risk of breast cancer. Lancet. 1993; 342:444. [PubMed 8101951]
243. Goodare H. Tamoxifen trial in healthy women at risk of breast cancer. Lancet. 1993; 342:444. [PubMed 8101952]
244. Hard GC, Williams GM, Iatropoulos MJ. Tamoxifen and liver cancer. Lancet. 1993; 342:444-5. [PubMed 8101953]
245. Phillips DH, Venitt S. Safety of prophylactic tamoxifen. Lancet. 1993; 341:1485-6. [IDIS 316254] [PubMed 8099187]
246. Powles TJ. The case for clinical trials of tamoxifen for prevention of breast cancer. Lancet. 1992; 340:1145-7. [IDIS 305013] [PubMed 1359221]
247. Fugh-Berman A, Epstein S. Tamoxifen: disease prevention or disease substitution? Lancet. 1992; 340:1143-5. Editorial.
248. Ernst E, Resch KL, Fialka V. Tamoxifen and prevention. Lancet. 1993; 341:694-5. [PubMed 8095599]
249. Fugh-Berman A, Epstein SS. Tamoxifen and prevention. Lancet. 1993; 341:695. [PubMed 8095600]
250. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92. [PubMed 10994034]
251. Ribeiro G. Male breast carcinoma—a review of 301 cases from the Christie Hospital and Holt Radium Institute, Manchester. Br J Cancer. 1985; 51:115-9. [PubMed 3966965]
252. Ribeiro G. Tamoxifen in the treatment of male breast carcinoma. Clin Radiol. 1983; 34:625-8. [PubMed 6673881]
253. Early Breast Cancer Trialists’ Collaborative Group. Part 1: Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy: 133 randomised trials involving 31 000 recurrences and 24 000 deaths among 75 000 women. Lancet. 1992; 339:1-15. [IDIS 290641] [PubMed 1345950]
254. Early Breast Cancer Trialists’ Collaborative Group. Part 2: Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy: 133 randomised trials involving 31 000 recurrences and 24 000 deaths among 75 000 women. Lancet. 1992; 339:71-85. [IDIS 289740] [PubMed 1345869]
255. Anon. Adjuvant systemic therapy for early breast cancer. Lancet. 1992; 339:27. [PubMed 1345955]
256. National Cancer Institute (NCI). NCI issues clinical announcement about long-term use of tamoxifen in breast cancer treatment. Bethesda, MD. 1995 Nov 30. Press release.
257. National Cancer Institute. Adjuvant therapy of breast cancer—tamoxifen update. Bethesda, MD. 1995 Nov 30. Clinical announcement.
258. Breast cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 1998 Dec.
259. Kedar RP, Bourne TH, Powles TJ et al. Effects of tamoxifen on uterus and ovaries of postmenopausal women in a randomised breast cancer prevention trial. Lancet. 1994; 343:1818-21.
260. Goldberg RM, Loprinzi CL, O’Fallon JR et al. Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. J Clin Oncol. 1994; 12:155-8. [IDIS 324702] [PubMed 8270972]
261. Love RR, Surawicz RS, Williams EC. Antithrombin III level, fibrinogen level, and platelet count changes with adjuvant tamoxifen therapy. Arch Intern Med. 1992; 152:317-20. [IDIS 291566] [PubMed 1739360]
262. Love RR, Cameron L, Connell BL et al. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991; 151:1842-7. [IDIS 287733] [PubMed 1888251]
263. McDonald CC, Stewart HJ. Fatal myocardial infarction in the Scottish adjuvant tamoxifen trial. BMJ. 1991; 303:435-7. [IDIS 284673] [PubMed 1912833]
264. Rutqvist LE, Mattsson A. Cardiac and thromboembolic morbidity among postmenopausal women with early-stage breast cancer in a randomized trial of adjuvant tamoxifen. J Natl Cancer Inst. 1993; 85:1398-1406. [PubMed 8350363]
265. Love RR, Mazess RB, Barden HS et al. Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer. N Engl J Med. 1992; 326:852-6. [IDIS 293033] [PubMed 1542321]
266. Kristensen B, Ejlertsen B, Dalgaard P et al. Tamoxifen and bone metabolism in postmenopausal low—risk breast cancer patients: a randomized study. J Clin Oncol. 1994; 12:992-7. [IDIS 330535] [PubMed 8164053]
267. Love RR, Barden HS, Mazess RB et al. Effect of tamoxifen on lumbar spine bone mineral density in postmenopausal women after 5 years. Arch Intern Med. 1994; 154:2585-8. [IDIS 339426] [PubMed 7979855]
268. Bentley CR, Davies G, Aclimandos WA. Tamoxifen retinopathy: a rare but serious complication. BMJ. 1992; 304:495-6. [IDIS 293593] [PubMed 1312376]
269. National Cancer Institute (NCI). Breast Cancer Prevention Trial shows major benefit, some risk. Bethesda, MD. 1998 Apr 6. Press release.
270. National Cancer Institute (NCI). Questions & answers: the Breast Cancer Prevention Trial. Bethesda, MD. 1998 Sep 14.
271. Prevention of breast cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 1998 Nov.
272. O’Shaughnessy JA. Chemoprevention of breast cancer. JAMA. 1996; 275:1349-53. [IDIS 364088] [PubMed 8614122]
273. Powles TJ, Jones AL, Ashley SE et al. The Royal Marsden Hospital pilot tamoxifen chemoprevention trial. Breast Cancer Res Treat. 1994; 31:73-82. [PubMed 7981459]
274. Kedar RP, Bourne TH, Powles TJ et al. Effects of tamoxifen on uterus and ovaries of postmenopausal women in a randomised breast cancer prevention trial. Lancet. 1994; 343:1318-21. [IDIS 330042] [PubMed 7910323]
275. Powles TJ, Hickish T, Kanis JA et al. Effect of tamoxifen on bone mineral density measured by dual-energy x-ray absorptiometry in healthy premenopausal and postmenopausal women. J Clin Oncol. 1996; 14:78-84. [IDIS 358669] [PubMed 8558225]
276. Harris JR, Lippman ME, Veronesi U et al. Breast cancer (3). N Engl J Med. 1992; 327:473-80. [IDIS 300160] [PubMed 1625737]
277. Ford LG, Johnson KA. Tamoxifen Breast Cancer Prevention Trial: an update. Prog Clin Biol Res. 1997; 396:271-82. [PubMed 9108604]
278. Redmond CK, Costantino JP. Design and current status of the NSABP breast cancer prevention trial. Recent Results Cancer Res. 1996; 140:309-17. [PubMed 8787073]
279. Jordan VC. An overview of considerations for the testing of tamoxifen as a preventive for breast cancer. Ann NY Acad Sci. 1995; 768:141-7. [PubMed 8526343]
280. Vogel VG, Saenz M. Tamoxifen for the prevention of breast cancer: yes. In: DeVita VT, Hellman S, Rosenberg SA, eds. Important advances in oncology. Philadelphia: JB Lippincott Company; 1995:187-200.
281. DeGregorio MW, Maenpaa JU, Wiebe VJ. Tamoxifen for the prevention of breast cancer: no. In: DeVita VT, Hellman S, Rosenberg SA, eds. Important advances in oncology. Philadelphia: JB Lippincott Company; 1995:175-85.
282. Anon. Nolvadex vs. Evista breast cancer prevention trial proposed by NSABP. FDC Rep. Apr 13, 1998:7-8.
283. Jordan VC. Tamoxifen: the herald of a new era of preventive therapeutics. J Natl Cancer Inst. 1997; 89:747-9. [IDIS 386402] [PubMed 9182965]
284. Ault A, Bradbury J. Experts argue about tamoxifen prevention trial. Lancet. 1998; 351:1107. [PubMed 9660593]
285. Morris K. IBIS tamoxifen trial to continue. Lancet. 1998; 351:1493. [PubMed 9605815]
286. Hankinson SE, Willett WC, Colditz GA et al. Circulating concentrations of insulin-like growth factor-I and risk of breast cancer. Lancet. 1998; 351:1393-6. [PubMed 9593409]
287. Holly J. Insulin-like growth factor-I and new opportunities for cancer prevention. Lancet. 1998; 351:1373-5. [PubMed 9593403]
288. Anon. Zeneca Nolvadex: Tamoxifen NDA supplement filed. FDC Rep. 1998 May 4:in brief.
289. Reviewer comments (personal observations).
290. Wickerham DL. Chemoprevention with tamoxifen reduces breast cancer incidence: results from NSABP P-1. Online coverage from the American Society of Clinical Oncology, May 16-19, 1998, on Medscape.
291. Fisher B, Dignam J, Bryant J et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996; 88:1529-42. [IDIS 376269] [PubMed 8901851]
292. Anon. SERM breast cancer prevention is subclinical disease therapy—ASCO. FDC Rep. 1998 May 25.
293. Fisher B, Costantino JP, Wickerham DL et al. Tamoxifen for the 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. [IDIS 414738] [PubMed 9747868]
294. Veronesi U, Maisonneuve P, Costa A et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women. Lancet. 1998; 352:93-7. [IDIS 409353] [PubMed 9672273]
295. Powles T, Eeles R, Ashley S et al. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet. 1998; 352:98-101. [IDIS 409354] [PubMed 9672274]
296. Anon. Interim reports published on two European breast cancer prevention trials. Bethesda, MD: National Cancer Institute; 1998 Jul 9.
297. Pritchard KI. Is tamoxifen effective in prevention of breast cancer? Lancet. 1998; 352:80-1.
298. Fisher B, Costantino JP, Redmond CK et al. Endometrial cancer in tamoxifen-treated breast cancer patients: findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14. J Natl Cancer Inst. 1994; 86:527-37. [IDIS 327970] [PubMed 8133536]
299. Goel V. Tamoxifen and breast cancer prevention: What should you tell your patients? CMAJ. 1998; 158:1615-7.
300. Bruzzi P. Tamoxifen for the prevention of breast cancer. Important questions remain unanswered, and existing trials should continue. BMJ. 1998; 316:1181-2. [IDIS 406737] [PubMed 9552991]
301. Karp SE, Tonin PN, Begin LR et al. Influence of BRCA1 mutations on nuclear grade and estrogen receptor status of breast carcinoma in Ashkenazi Jewish women. Cancer. 1997; 80:435-41. [PubMed 9241077]
302. Anon. Nolvadex BRCA1/2 study IRB approval expected by October. FDC Rep. September 21, 1998:16.
303. National Cancer Institute (NCI). Tamoxifen and breast cancer prevention: assessing risk. Bethesda, MD. 1998 Sep 14.
304. Anon. Nolvadex breast cancer prevention registry should be developed. FDC Rep. September 7, 1998.
305. Trock BJ. Breast cancer in African American women: epidemiology and tumor biology. Breast Cancer Res Treat. 1996; 40:11-24. [PubMed 8888149]
306. Elledge RM, Clark GM, Chamness GC et al. Tumor biologic factors and breast cancer prognosis among white, Hispanic, and black women in the United States. J Natl Cancer Inst. 1994; 86:705-12. [PubMed 7908990]
307. Oncologic Drugs Advisory Committee Meeting. 58th meeting. Bethesda, MD: Food and Drug Administration; 1998 Sep 2.
308. Food and Drug Administration. Tamoxifen approved for reducing breast cancer incidence. Rockville, MD. 1998 Oct 29. Press release.
309. Zeneca Pharmaceuticals. Landmark findings from Breast Cancer Prevention Trial lead FDA to approve Zeneca s Nolvadex (tamoxifen citrate) for the reduction of breast cancer in women at high risk. Wilmington, DE. 1998 Oct 29. Press release.
310. Private Citizen. FDA s approval of tamoxifen to reduce incidence of breast cancer in healthy women puts women at risk. Washington, DC. 1998 Oct 29. Press release.
311. Robinson E, Kimmick GG, Muss HB. Tamoxifen in postmenopausal women: a safety perspective. Drugs Aging. 1996; 8:329-37. [PubMed 8935395]
312. Stewart PJ, Stern PH. Effects of the antiestrogens tamoxifen and clomiphene on bone resorption in vitro. Endocrinology. 1986; 118:125-31. [PubMed 3455681]
313. Turner RT, Wakley GK, Hannon KS et al. Tamoxifen inhibits osteoclast-mediated resorption of trabecular bone in ovarian hormone-deficient rats. Endocrinology. 1988; 122:1146-50. [PubMed 3342747]
314. Turner RT, Wakley GK, Hannon KS et al. Tamoxifen prevents the skeletal effects of ovarian hormone deficiency in rats. J Bone Miner Res. 1987; 2:449-56. [PubMed 3455628]
315. Jordan VC, Phelps E, Lindgren JU. Effects of anti-estrogens on bone in castrated and intact female rats. Breast Cancer Res Treat. 1987; 10:31-5. [PubMed 3689979]
316. Grey AB, Stapleton JP, Evans MC et al. The effect of the antiestrogen tamoxifen on bone mineral density in normal late menopausal women. Am J Med. 1995; 99:636-41. [IDIS 360184] [PubMed 7503087]
317. Davidson NE. Tamoxifen—panacea or Pandora’s box? N Engl J Med. 1992; 326:885-6.
318. Dewar JA, Horobin JM, Preece PE et al. Long term effects of tamoxifen on blood lipid values in breast cancer. BMJ. 1992; 305:225-6. [IDIS 299989] [PubMed 1392827]
319. Love RR, Newcomb PA, Wiebe DA et al. Effects of tamoxifen therapy on lipid and lipoprotein levels in postmenopausal patients with node-negative breast cancer. J Natl Cancer Inst. 1990; 82:1327-32. [PubMed 2199681]
320. Love RR, Wiebe DA, Newcomb PA et al. Effects of tamoxifen on cardiovascular risk factors in postmenopausal women. Ann Intern Med. 1991; 115:860-4. [IDIS 288467] [PubMed 1952472]
321. McDonald CC, Alexander FE, Whyte BW et al. Cardiac and vascular morbidity in women receiving adjuvant tamoxifen for breast cancer in a randomised trial. BMJ. 1995; 311:977-80. [IDIS 356103] [PubMed 7580638]
322. Costantino JP, Kuller LH, Ives DG et al. Coronary heart disease mortality and adjuvant tamoxifen therapy. J Natl Cancer Inst. 1997; 89:776-82. [IDIS 386404] [PubMed 9182975]
323. Pollak M, Costantino J, Polychronakos C et al. Effect of tamoxifen on serum insulinlike growth factor I levels in stage I breast cancer patients. J Natl Cancer Inst. 1990; 82:1693-7. [PubMed 2231756]
324. Kanel KT, Wolmark N, Thompson PD. Delayed severe hypertriglyceridemia from tamoxifen. N Engl J Med. 1997; 337:281. [IDIS 388328] [PubMed 9229698]
325. Mikhailidis DP, Ganotakis ES, Georgoulias VA et al. Tamoxifen-induced hypertriglyceridemia: seven case reports and suggestions for remedial action. Oncol Rep. 1997; 4:625-8. [PubMed 21590112]
326. Gorin MB, Day R, Costantino JP et al. Long-term tamoxifen citrate use and potential ocular toxicity. Am J Ophthalmol. 1998; 125:493-501. [IDIS 403221] [PubMed 9559735]
327. Early Breast Cancer Trialists’ Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet. 1998; 351:1451-67. [IDIS 405126] [PubMed 9605801]
328. Swedish Breast Cancer Cooperative Group. Randomized trial of two versus five years of adjuvant tamoxifen for postmenopausal early stage breast cancer. J Natl Cancer Inst. 1996; 88:1543-9. [IDIS 376270] [PubMed 8901852]
329. Osborne CK. Tamoxifen in the treatment of breast cancer. N Engl J Med. 1998; 339:1609-18. [IDIS 416327] [PubMed 9828250]
330. Purvis J. Dear doctor letter regarding warning information on serious or fatal adverse effects among women receiving tamoxifen for risk reduction. Wilmington, DE: AstraZeneca Pharmaceuticals; 2002 May 15.
a. AstraZeneca Pharmaceuticals. Nolvadex (tamoxifen citrate) prescribing information. Wilmington, DE; 2003 Jun.
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