Current approaches to the management of Her2-negative metastatic breast cancer

Breast Cancer Research

Volumn 14, Issue 2, 2012, Pages

  Gogineni, Keerthi ^a,b   DeMichele, Angela ^a,b,c  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Center for Clinical Epidemiology and Biostatistics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; ANTHRACYCLINE; BEVACIZUMAB; BUSERELIN; CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ERIBULIN; ESTRADIOL; ESTROGEN RECEPTOR; EVEROLIMUS; EXEMESTANE; FULVESTRANT; GEMCITABINE; GOSERELIN; INIPARIB; IXABEPILONE; LETROZOLE; MEGESTROL; NAVELBINE; OLAPARIB; PACLITAXEL; PROGESTERONE RECEPTOR; RAMUCIRUMAB; TAMOXIFEN; UNINDEXED DRUG; VOROZOLE; ANTINEOPLASTIC ANTIMETABOLITE; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; AROMATASE INHIBITOR; DEOXYCYTIDINE; DRUG DERIVATIVE; ERBB2 PROTEIN, HUMAN; MTOR PROTEIN, HUMAN; TARGET OF RAPAMYCIN KINASE;

ABLATION THERAPY; BONE MARROW TOXICITY; BREAST METASTASIS; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER HORMONE THERAPY; CARDIOTOXICITY; DIARRHEA; FEBRILE NEUTROPENIA; FEMALE; FLUID RETENTION; GENE OVEREXPRESSION; HUMAN; INFECTION; META ANALYSIS (TOPIC); MOLECULARLY TARGETED THERAPY; NAIL DISEASE; NAUSEA AND VOMITING; NEUROPATHY; OVULATION INHIBITION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHENOTYPE; POSTMENOPAUSE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; TRIPLE NEGATIVE BREAST CANCER; BREAST TUMOR; DRUG ANTAGONISM; DRUG EFFECT; METABOLISM; OVARY; PATHOLOGY;

ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; DEOXYCYTIDINE; DOXORUBICIN; ESTRADIOL; FEMALE; HUMANS; MEGESTROL; OVARY; RECEPTOR, ERBB-2; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TAMOXIFEN; TOR SERINE-THREONINE KINASES;

EID: 84858737409     PISSN: 14655411     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr3064     Document Type: Review

References (86)

1. Howlader N, Noone AM, Krapcho M, Neyman N, Aminou R, Waldron W, Altekruse SF, Kosary CL, Ruhl J, Tatalovich Z, Cho H, Mariotto A, Eisner MP, Lewis DR, Chen HS, Feuer EJ, Cronin KA, Edwards BK (. SEER Cancer Statistics Review, 1975-2008 Bethesda, MD: National Cancer Institute., http://seer.cancer.gov/csr/1975_2008/
2. Khatcheressian JL, Wolff AC, Smith TJ, Grunfeld E, Muss HB, Vogel VG, Halberg F, Somerfield MR, Davidson NE, . American Society of Clinical Oncology American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guideline in the adjuvant Setting. J Clin Oncol 2006, 2:5091-5097. American Society of Clinical Oncology.
3. NCCN Guidelines Breast Cancer Version 2.2011. , http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
4. Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S, Somerfield MR, Hayes DF, Bast RC, . American Society of Clinical Oncology American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2007, 25:5287-5312. 10.1200/JCO.2007.14.2364, 17954709, American Society of Clinical Oncology.
5. Pusztai L, Viale G, Kelly CM, Hudis CA. Estrogen and HER-2 receptor discordance between primary breast cancer and metastasis. Oncologist 2010, 15:1164-1168. 10.1634/theoncologist.2010-0059, 21041379.
6. Mi Z, Holmes FA, Hellerstedt B, Pippen J, Collea R, Backner A, Bush JE, Gallion HH, Wells A, O'Shaughnessy JA. Feasibility assessment of a chemoresponse assay to predict pathologic response in neoadjuvant chemotherapy for breast cancer patients. Anticancer Res 2008, 28:1733-1740.
7. Baselga J, Campone M, Piccart M, Burris H, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, M Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2011,
8. 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, 365:1687-1717. Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
9. NCI Drug Dictionary. , http://www.cancer.gov/drugdictionary
10. Ingle JN, Krook JE, Green SJ, Kubista TP, Everson LK, Ahmann DL, Chang MN, Bisel HF, Windschitl HE, Twito DI, Pfiefle DM. Randomized trial of bilateral oopherectomy versus tamoxifen in premenopausal women with metastatic breast cancer. J Clin Oncol 1986, 4:178-185.
11. Boccardo F, Rubagotti A, Perrotta A, Amoroso D, Balestrero M, De Matteis A, Zola P, Sismondi P, Francini G, Petrioli R, Sassi M, Pacini P, Galligioni E. Ovarian ablation versus goserelin with or without tamoxifen in pre-perimenopausal patients with advanced breast cancer: results of a multicentric Italian study. Ann Oncol 1994, 5:337-342.
12. Klijn JG, Blamey RW, Boccardo F, Tominaga T, Duchateau L, Sylvester R, . Combined Hormone Agents Trialists' Group and the European Organization for Research and Treatment of Cancer Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol 2001, 19:343-353. Combined Hormone Agents Trialists' Group and the European Organization for Research and Treatment of Cancer.
13. Hughes LL, Gray RJ, Solin LJ, Robert NJ, Martino S, Tripathy D, Ingle JN, Wood WC, . Eastern Cooperative Oncology Group; Southwest Oncology Group; Cancer and Leukemia Group B; North Central Cancer Treatment Group Efficacy of radiotherapy for ovarian ablation: results of a breast intergroup study. Cancer 2004, 101:969-972. 10.1002/cncr.20481, 15329905, Eastern Cooperative Oncology Group; Southwest Oncology Group; Cancer and Leukemia Group B; North Central Cancer Treatment Group.
14. Sverrisdottir A, Johansson H, Johansson U, Bergh J, Rotstein S, Rutqvist LE, Fornander T. Interaction between goserelin and tamoxifen in a controlled clinical trial of adjuvant endocrine therapy in premenopausal breast cancer. San Antonio Breast Cancer Symposium 2010, S1-5.
15. Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010, 28:4594-4600. 10.1200/JCO.2010.28.8415, 20855825.
16. Ingle JN, Suman VJ, Rowland KM, Mirchandani D, Bernath AM, Camoriano JK, Fishkin PA, Nikcevich DA, Perez EA, . North Central Cancer Treatment Group Trial N0032 Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol 2006, 24:1052-1056. 10.1200/JCO.2005.04.1053, 16505423, North Central Cancer Treatment Group Trial N0032.
17. Robertson JF, Llombart-Cussac A, Rolski J, Feltl D, Dewar J, Macpherson E, Lindemann J, Ellis MJ. Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. J Clin Oncol 2009, 27:4530-4535. 10.1200/JCO.2008.21.1136, 19704066.
18. Goss PE, Winer EP, Tannock IF, Schwartz LH. Randomized phase III trial comparing the new potent and selective third-generation aromatase inhibitor vorozole with megestrol acetate in postmenopausal advanced breast cancer patients. J Clin Oncol 1999, 17:52-63.
19. Shattuck DL, Miller JK, Carraway KL, Sweeney C. Met receptor contributes to trastuzumab resistance of Her2-overexpressing breast cancer cells. Cancer Res 2008, 68:1471-1477. 10.1158/0008-5472.CAN-07-5962, 18316611.
20. Bonneterre J, Buzdar A, Nabholtz JM, Robertson JF, Thürlimann B, von Euler M, Sahmoud T, Webster A, Steinberg M, . Arimidex Writing Committee; Investigators Committee Members Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer 2001, 92:2247-2258. 10.1002/1097-0142(20011101)92:9<2247::AID-CNCR1570>3.0.CO;2-Y, 11745278, Arimidex Writing Committee; Investigators Committee Members.
21. Mouridsen H, Sun Y, Gershanovich M, Perez-Carrion R, Becquart D, ChaudriRoss HA, Lang R. Superiority of letrozole to tamoxifen in the first-line treatment of advanced breast cancer: evidence from metastatic subgroups and a test of functional ability. Oncologist 2004, 9:489-496. 10.1634/theoncologist.9-5-489, 15477633.
22. Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol 2008, 26:4883-4890. 10.1200/JCO.2007.14.4659, 2652082, 18794551.
23. Kaufmann M, Bajetta E, Dirix LY, Fein LE, Jones SE, Zilembo N, Dugardyn JL, Nasurdi C, Mennel RG, Cervek J, Fowst C, Polli A, di Salle E, Arkhipov A, Piscitelli G, Miller LL, Massimini G. Exemestane improves survival in metastatic breast cancer: results of a phase III randomized study. Clin Breast Cancer 2000, 1(suppl 1):S15-18.
24. Campos SM, Guastalla JP, Subar M, Abreu P, Winer EP, Cameron DA. A comparative study of exemestane versus anastrozole in patients with postmenopausal breast cancer with visceral metastases. Clin Breast Cancer 2009, 9:39-44. 10.3816/CBC.2009.n.007, 19299239.
25. Brufman G, Isacson R, Haim N, Gez E, Sulkes A. Megestrol acetate in advanced breast carcinoma after failure to tamoxifen and/or aminoglutethimide. Oncology 1994, 51:258-261. 10.1159/000227345, 8196908.
26. Ellis MJ, Gao F, Dehdashti F, Jeffe DB, Marcom PK, Carey LA, Dickler MN, Silverman P, Fleming GF, Kommareddy A, Jamalabadi-Majidi S, Crowder R, Siegel BA. Lower-dose vs. high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study. JAMA 2009, 302:774-780. 10.1001/jama.2009.1204, 19690310.
27. Kaufman PA, Ferrero JM, Bourgeois H, Kennecke H, De Boer R, Jacot W, McGreivy J, Suzuki S, Loh E, Robertson J. A randomized, double-blind, placebo-controlled, phase 2 study of AMG 479 with exemestane (E) or fulvestrant (F) in postmenopausal women with hormone-receptor positive (HR+) metastatic (M) or locally advanced (LA) breast cancer (BC) [abstract]. San Antonio Breast Cancer Symposium 2010, S1-4.
28. Bachelot T, Bourgier C, Cropet C, Guastalla J-P, Ferrero J-M, Leger-Falandry C, Soulie P, Eymard J-C, Debled M, Spaeth D, Legouffe E, Delozier T, El Kouri C, Chidiac J. TAMRAD: a GINECO randomized phase II trial of everolimus in combination with tamoxifen versus tamoxifen alone in patients (pts) with hormone-receptor positive, HER2 negative metastatic breast cancer (MBC) with prior exposure to aromatase inhibitors (AI) [abstract]. San Antonio Breast Cancer Symposium 2010, S1-6.
29. Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol 2010, 28:3271-3277. 10.1200/JCO.2009.25.9820, 20498394.
30. Chan S, Friedrichs K, Noel D, Pintér T, Van Belle S, Vorobiof D, Duarte R, Gil Gil M, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, González Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A, Crown J, . 303 Study Group Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999, 17:2341-2454. 303 Study Group.
31. Bastholt L, Dalmark M, Gjedde SB, Pfeiffer P, Pedersen D, Sandberg E, Kjaer M, Mouridsen HT, Rose C, Nielsen OS, Jakobsen P, Bentzen SM. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol 1996, 14:1146-1166.
32. O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C, . CAELYX Breast Cancer Study Group Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004, 15:440-449. 10.1093/annonc/mdh097, 14998846, CAELYX Breast Cancer Study Group.
33. Jones SE, Erban J, Overmoyer B, Budd GT, Hutchins L, Lower E, Laufman L, Sundaram S, Urba WJ, Pritchard KI, Mennel R, Richards D, Olsen S, Meyers ML, Ravdin PM. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 2005, 23:5542-5551. 10.1200/JCO.2005.02.027, 16110015.
34. Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 2008, 26:1642-1649. 10.1200/JCO.2007.11.6699, 18375893.
35. Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol 2001, 19:4216-4223.
36. Burris HA. Single-agent docetaxel (Taxotere) in randomized phase III trials. Semin Oncol 1999, 26(3 suppl 9):1-6.
37. Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, Matulonis UA, Garber JE, Clarke KD, Shulman LN, Winer EP. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000, 18:1212-1219.
38. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005, 23:7794-7803. 10.1200/JCO.2005.04.937, 16172456.
39. Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009, 27:3611-3619. 10.1200/JCO.2008.18.5397, 19470941.
40. Zelek L, Barthier S, Riofrio M, Fizazi K, Rixe O, Delord JP, Le Cesne A, Spielmann M. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 2001, 92:2267-2272. 10.1002/1097-0142(20011101)92:9<2267::AID-CNCR1572>3.0.CO;2-Q, 11745280.
41. Roché H, Yelle L, Cognetti F, Mauriac L, Bunnell C, Sparano J, Kerbrat P, Delord JP, Vahdat L, Peck R, Lebwohl D, Ezzeddine R, Curé H. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy. J Clin Oncol 2007, 25:3415-3420. 10.1200/JCO.2006.09.7535, 17606972.
42. Rivera E, Gomez H. Chemotherapy resistance in metastatic breast cancer:the evolving role of ixabepilone. Breast Cancer Res 2010, 12(suppl 2):1-12.
43. Denduluri N, Low JA, Lee JJ, Berman AW, Walshe JM, Vatas U, Chow CK, Steinberg SM, Yang SX, Swain SM. Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes. J Clin Oncol 2007, 25:3421-3427. 10.1200/JCO.2006.10.0784, 17606971.
44. Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol 2007, 25:3407-3414. 10.1200/JCO.2006.09.3849, 17606974.
45. Thomas E, Tabernero J, Fornier M, Conté P, Fumoleau P, Lluch A, Vahdat LT, Bunnell CA, Burris HA, Viens P, Baselga J, Rivera E, Guarneri V, Poulart V, Klimovsky J, Lebwohl D, Martin M. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol 2007, 25:3399-3406. 10.1200/JCO.2006.08.9102, 17606975.
46. Cortes J, Vahdat L, Blum JL, Twelves C, Campone M, Roché H, Bachelot T, Awada A, Paridaens R, Goncalves A, Shuster DE, Wanders J, Fang F, Gurnani R, Richmond E, Cole PE, Ashworth S, Allison MA. Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol 2010, 28:3922-3928. 10.1200/JCO.2009.25.8467, 20679609.
47. Vahdat LT, Pruitt B, Fabian CJ, Rivera RR, Smith DA, Tan-Chiu E, Wright J, Tan AR, Dacosta NA, Chuang E, Smith J, O'Shaughnessy J, Shuster DE, Meneses NL, Chandrawansa K, Fang F, Cole PE, Ashworth S, Blum JL. Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2009, 27:2954-2961. 10.1200/JCO.2008.17.7618, 19349550.
48. Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C, . EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011, 377:914-923. 10.1016/S0140-6736(11)60070-6, 21376385, EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators.
49. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast cancer. Cancer 2001, 92:1759-1768. 10.1002/1097-0142(20011001)92:7<1759::AID-CNCR1691>3.0.CO;2-A, 11745247.
50. O'Shaugh nessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002, 20:2812-2823. 10.1200/JCO.2002.09.002, 12065558.
51. Bajetta E, Procopio G, Celio L, Gattinoni L, Della Torre S, Mariani L, Catena L, Ricotta R, Longarini R, Zilembo N, Buzzoni R. Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol 2005, 23:2155-2161. 10.1200/JCO.2005.02.167, 15710946.
52. Blackste in M, Vogel CL, Ambinder R, Cowan J, Iglesias J, Melemed A. Gemcitabine as first-line therapy in patients with metastatic breast cancer: a phase II trial. Oncology 2002, 62:2-8.
53. Rha SY, Moon YH, Jeung HC, Kim YT, Sohn JH, Yang WI, Suh CO, Kim GE, Roh JK, Chung HC. Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer. Breast Cancer Res Treat 2005, 90:215-221. 10.1007/s10549-004-2468-4, 15830134.
54. Albain K S, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS, Simms L, O'Shaughnessy J. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 2008, 26:3950-3957. 10.1200/JCO.2007.11.9362, 18711184.
55. Mauri D, Kamposioras K, Tsali L, Bristianou M, Valachis A, Karathanasi I, Georgiou C, Polyzos NP. Overall survival benefit for weekly vs. three-weekly taxanes regimens in advanced breast cancer: a meta-analysis. Cancer Treat Rev 2009, 36:69-74.
56. Sparano JA, Vrdoljak E, Rixe O, Xu B, Manikhas A, Medina C, Da Costa SC, Ro J, Rubio G, Rondinon M, Perez Manga G, Peck R, Poulart V, Conte P. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2010, 28:3256-3263. 10.1200/JCO.2009.24.4244, 2903325, 20530276.
57. Sirohi B, Arnedos M, Popat S, Ashley S, Nerurkar A, Walsh G, Johnston S, Smith IE. Platinum-based chemotherapy in triple negative breast cancer. Ann Oncol 2008, 19:1847-1852. 10.1093/annonc/mdn395, 18567607.
58. Wang Z, Hu X, Chen L, Wang J, Wang H, Wang L, Liu G, Hu Z, Wu J, Zhimin S. Efficacy of gemcitabine and cisplatin (GP) as first-line combination therapy in patients with triple-negative metastatic breast cancer: preliminary results report of a phase II trial [abstract]. J Clin Oncol 2010, 28(suppl):e1100.
59. Chew HK, Doroshow JH, Frankel P, Margolin KA, Somlo G, Lenz HJ, Gordon M, Zhang W, Yang D, Russell C, Spicer D, Synold T, Bayer R, Hantel A, Stiff PJ, Tetef ML, Gandara DR, Albain KS. Phase II studies of gemcitabine and cisplatin in heavily and minimally pretreated metastatic breast cancer. J Clin Oncol 2009, 27:2163-2169. 10.1200/JCO.2008.17.4839, 2674003, 19307510.
60. Staudacher L, Cottu PH, Diéras V, Vincent-Salomon A, Guilhaume MN, Escalup L, Dorval T, Beuzeboc P, Mignot L, Pierga JY. Platinum-based chemotherapy in metastatic triple-negative breast cancer: the Institut Curie experience. Ann Oncol 2011, 22:848-856. 10.1093/annonc/mdq461, 20924076.
61. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007, 357:2666-2676. 10.1056/NEJMoa072113, 18160686.
62. Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G. 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, 28:3239-3247. 10.1200/JCO.2008.21.6457, 20498403.
63. Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005, 23:792-798. 10.1200/JCO.2005.05.098, 15681523.
64. Robert NJ, Diéras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011, 29:1252-1260. 10.1200/JCO.2010.28.0982, 21383283.
65. Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiełło-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Baños A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010I. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol 2011, 4:369-376.
66. National Institute for Health and Clinical Excellence Guide line for] Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer. National Institute for Health and Clinical Excellence., http://guidance.nice.org.uk/TA214
67. Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin). Washington, DC: US Food and Drug Administration; 28-29 June 2011. , http://www.fda.gov/newsevents/meetingsconferencesworkshops/ucm255874.htm
68. O'Shaughnessy J, Schwartzberg LS, Danso MA, Rugo HS, Miller K, Yardley DA, Carlson RW, Finn RS, Charpentier E, Freese M, Gupta S, Blackwood-Chirchir A, Winer EP. A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC) [abstract]. J Clin Oncol 2011, 29(Suppl):e1007.
69. O'Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, Koo IC, Sherman BM, Bradley C. Iniparib plus chemotherapy in metastatic triplenegative breast cancer. N Engl J Med 2011, 364:205-214. 10.1056/NEJMoa1011418, 21208101.
70. Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet 2010, 376:235-244. 10.1016/S0140-6736(10)60892-6, 20609467.
71. Isakoff SJ, Overmoyer B, Tung NM, Gelman RS, Giranda VL, Bernhard KM, Habin KR, Ellisen LW, Winer EP, Goss PE. A phase II trial of the PARP inhibitor veliparib (ABT888) and temozolomide for metastatic breast cancer [abstract]. J Clin Oncol 2010, 28(Suppl):e1019.
72. Bergh J, Greil R, Voytko N, Makhson A, Cortes J, Lortholary A, Huang X, Giorgetti C, Kern KA, Lichinitser M. Sunitinib (SU) in combination with docetaxel (D) versus D alone for the first-line treatment of advanced breast cancer (ABC) [abstract]. J Clin Oncol 2010, 28(Suppl):LBA1010.
73. Ponzo MG, Lesurf R, Petkiewicz S, O'Malley FP, Pinnaduwage D, Andrulis IL, Bull SB, Chughtai N, Zuo D, Souleimanova M, Germain D, Omeroglu A, Cardiff RD, Hallett M, Park M. Met induces mammary tumors with diverse histologies and is associated with poor outcome and human basal breast cancer. Proc Natl Acad Sci USA 2009, 106:12903-12908. 10.1073/pnas.0810402106, 2722321, 19617568.
74. Adjei A, Sosman J, Martell R, Dy G, Goff L, Ma W, Horn L, Fetterly G, Michael A, Means J, Chai F, Lamar M, Strauss G, Chiang W, Jarboe J, Schwartz B, Puzanov I. Efficacy in selected tumor types in a phase I study of the c-MET inhibitor ARQ 197 in combination with sorafenib. J Clin Oncol 2011, 29(Suppl):3034.
75. Camacho L, Pant S, Saleh M, Abbadessa G, Kazakin J, Schwartz B, Bendell J. Phase Ib results of c-MET inhibitor ARQ 197 in combination with gemcitabine in a cohort of patients (pts) with advanced breast, ovarian, and uterine tumors. J Clin Oncol 2011, 29(Suppl):3077.
76. Donehower R, Scardina A, Hill M, Bowman J, Newton R, Liu X, Scherle P, Wang Q, Diamond S, Boer J, Lee F, Gau T, Burris H, Bendell J, Jones S, Infante J. A phase I dose-escalation study of INCB028060, an inhibitor of c-MET receptor tyrosine kinase, in patients with advanced solid tumors. J Clin Oncol 2011, 29(Suppl):3091.
77. Kuss JT, Muss HB, Hoen H, Case LD. Tamoxifen as initial endocrine therapy for metastatic breast cancer: long term follow-up of two Piedmont Oncology Association (POA) trials. Breast Cancer Res Treat 1997, 42:265-274. 10.1023/A:1005758127114, 9065610.
78. Klijn JG, Beex LV, Mauriac L, van Zijl JA, Veyret C, Wildiers J, Jassem J, Piccart M, Burghouts J, Becquart D, Seynaeve C, Mignolet F, Duchateau L. Combined treatment with buserelin and tamoxifen in premenopausal metastatic breast cancer: a randomized study. J Natl Cancer Inst 2000, 92:903-911. 10.1093/jnci/92.11.903, 10841825.
79. Howell A, Robertson JF, Abram P, Lichinitser MR, Elledge R, Bajetta E, Watanabe T, Morris C, Webster A, Dimery I, Osborne CK. Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. J Clin Oncol 2004, 22:1605-1613. 10.1200/JCO.2004.02.112, 15117982.
80. Thürlimann B, Hess D, Köberle D, Senn I, Ballabeni P, Pagani O, Perey L, Aebi S, Rochlitz C, Goldhirsch A. Anastrozole ('Arimidex') versus tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer: results of the double-blind cross-over SAKK trial 21/95--a sub-study of the TARGET (Tamoxifen or 'Arimidex' Randomized Group Efficacy and Tolerability) trial. Breast Cancer Res Treat 2004, 85:247-254. 10.1023/B:BREA.0000025420.78346.f9, 15111763.
81. Mouridsen H, Gershanovich M, Sun Y, Pérez-Carrión R, Boni C, Monnier A, Apffelstaedt J, Smith R, Sleeboom HP, Jänicke F, Pluzanska A, Dank M, Becquart D, Bapsy PP, Salminen E, Snyder R, Lassus M, Verbeek JA, Staffler B, Chaudri-Ross HA, Dugan M. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol 2001, 19:2596-2606.
82. Muss HB, Case LD, Atkins JN, Bearden JD, Cooper MR, Cruz JM, Jackson DV, O'Rourke MA, Pavy MD, Powell BL, Richards F, Spurr CL, Eagle K, White DR. Tamoxifen versus high-dose oral medroxyprogesterone acetate as initial endocrine therapy for patients with metastatic breast cancer: A Piedmont Oncology Association Study. J Clin Oncol 1994, 12:1630-1638.
83. Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J, Hakes T, Baselga J, Sklarin N, Moynihan ME, Tong W, Egorin M, Kearns C, Spriggs D, Norton L. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol 1995, 13:2575-2581.
84. Oshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R, Mauriac L, Osterwalder B, Burger HU, Laws S. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 2001, 12:1247-1254. 10.1023/A:1012281104865, 11697835.
85. Carmichael J, Possinger K, Phillip P, Beykirch M, Kerr H, Walling J, Harris AL. Advanced breast cancer: a phase II trial with gemcitabine. J Clin Oncol 1995, 13:2731-2736.
86. ClinicalTrials.gov homepage. , http://www.clinicaltrials.gov/