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References: Breast cancer

183 sources cited on this page. Links open the primary source.

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  36. Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349(6):546-53. PubMedDOI
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  38. Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;366(9503):2087-106. PubMedDOI
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  39. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687-717. PubMedDOI
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  40. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-72. PubMedDOI
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  41. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-84. PubMedDOI
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  42. Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005;353(26):2747-57. PubMedDOI
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  43. US Food and Drug Administration. Supplement approval letter, trastuzumab (Herceptin), BL 103792/5150, Genentech, Inc.; letter dated 16 November 2006. Source
  44. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357(26):2666-76. PubMedDOI
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  45. FDA. Approval letter, BL 125085/91 (Avastin, bevacizumab; accelerated approval for metastatic HER2-negative breast cancer), 22 February 2008. Source
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  47. Jordan VC. A century of deciphering the control mechanisms of sex steroid action in breast and prostate cancer: the origins of targeted therapy and chemoprevention. Cancer Res. 2009;69(4):1243-54. PubMedDOI
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  48. Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010;11(12):1135-41. PubMedDOI
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  49. FDA CDER. Regulatory Decision to Withdraw Avastin (bevacizumab) First-line Metastatic Breast Cancer Indication. Memorandum to the File, BLA 125085, 15 December 2010. Source
  50. Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11(10):927-33. PubMedDOI
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  51. Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-47. PubMedDOI
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  52. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011;378(9804):1707-16. PubMedDOI
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  53. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011;378(9793):771-84. PubMedDOI
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  54. FDA. Supplement approval letter, BLA 125085/241 (Avastin, bevacizumab; removal of the metastatic breast cancer indication from the label), 20 December 2011. Source
  55. Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305(6):569-75. PubMedDOI
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  57. Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109-19. PubMedDOI
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  58. US Food and Drug Administration. BLA approval letter, Perjeta (pertuzumab), BLA 125409/0, Genentech, Inc.; signed 8 June 2012. Source
  59. FDA. Final Decision on Withdrawal of Breast Cancer Indication for AVASTIN (Bevacizumab) Following Public Hearing; Availability. Fed Regist. 2012 Feb 27;77(38):11554-11555 (Docket FDA-2010-N-0621). Source
  60. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012;380(9855):1778-86. PubMedDOI
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  61. Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91. PubMedDOI
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  62. US Food and Drug Administration. BLA approval letter, Kadcyla (ado-trastuzumab emtansine), BLA 125427/0, Genentech, Inc.; signed 22 February 2013. Source
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  65. Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ. 2014;348:g366. PubMedDOI
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  67. US Food and Drug Administration. Approval letter, NDA 207103 (Ibrance, palbociclib), signed 3 February 2015. Source
  68. Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015;16(3):266-73. PubMedDOI
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  70. Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016;375(8):717-29. PubMedDOI
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  71. European Medicines Agency. Ibrance: EPAR (marketing authorisation issued 9 November 2016; page updated 19 May 2026). Source
  72. Farquhar C, Marjoribanks J, Lethaby A, Azhar M. High-dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with early poor prognosis breast cancer. Cochrane Database Syst Rev. 2016;2016(5):CD003139. PubMedDOI
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  74. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016;375(18):1738-1748. PubMedDOI
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  76. European Medicines Agency. Kisqali: EPAR (marketing authorisation issued 22 August 2017). Source
  77. US Food and Drug Administration. Approval letter, NDA 209092 (Kisqali, ribociclib), signed 13 March 2017. Source
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  80. Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, et al. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017;317(23):2402-2416. PubMedDOI
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  84. André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380(20):1929-1940. PubMedDOI
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  85. FDA. FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. Notice, content current as of 18 March 2019. Source
  86. US Food and Drug Administration. Supplement approval letter, Kadcyla (ado-trastuzumab emtansine), BLA 125427/S-105, Genentech, Inc.; signed 3 May 2019. Source
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  89. Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020;396(10265):1817-1828. PubMedDOI
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  90. FDA. Accelerated approval letter, BLA 125514/S-088 (Keytruda, pembrolizumab), signed 13 November 2020. Source
  91. FDA. Accelerated approval letter, BLA 761115 (Trodelvy, sacituzumab govitecan-hziy), signed 22 April 2020. Source
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  94. Swain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(4):519-530. PubMedDOI
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  95. André F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021;32(2):208-217. PubMedDOI
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  97. Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, et al. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Ann Oncol. 2021;32(8):983-993. PubMedDOI
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  98. FDA. Supplement approval letter, BLA 761034/S-044 (Tecentriq, atezolizumab; removal of an indication approved under accelerated approval), signed 6 October 2021. Source
  99. FDA. Supplement approval letter, BLA 125514/S-089 and S-114 (Keytruda, pembrolizumab), signed 26 July 2021. Source
  100. FDA. Supplement approval letter, BLA 761115/S-005 and S-013 (Trodelvy, sacituzumab govitecan-hziy), signed 7 April 2021. Source
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  103. Miles D, Gligorov J, André F, Cameron D, Schneeweiss A, Barrios C, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021;32(8):994-1004. PubMedDOI
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  105. Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021;384(25):2394-2405. PubMedDOI
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  109. FDA. Corrected supplement approval letter, NDA 208558/S-023 (Lynparza, olaparib), signed 11 March 2022. Source
  110. US Food and Drug Administration. Corrected supplement approval letter, Enhertu (fam-trastuzumab deruxtecan-nxki), BLA 761139/S-022, Daiichi Sankyo, Inc.; effective action date 5 August 2022. Source
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