Randomised, phase II, placebo-controlled, trial of fulvestrant plus vandetanib in postmenopausal women with bone only or bone predominant, hormone-receptor-positive metastatic breast cancer (MBC): The OCOG ZAMBONEY study

Breast Cancer Research and Treatment

Volumn 146, Issue 1, 2014, Pages 153-162

  Clemons, Mark J ^a   Cochrane, Brandy ^b   Pond, Gregory R ^b   Califaretti, Nadia ^c   Chia, Stephen K L ^d   Dent, Rebecca Alexandra ^e   Song, Xinni ^a   Robidoux, Andre ^f   Parpia, Sameer ^b   Warr, David ^g   Rayson, Daniel ^h   Pritchard, Kathleen I ^e   Levine, Mark N ^b  

^a OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c Grand River Regional Cancer Centre   (Canada)

^d BRITISH COLUMBIA CANCER AGENCY   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^g PRINCESS MARGARET HOSPITAL   (Canada)

^h QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

Author keywords

Bone metastases; Breast cancer; Fulvestrant; Postmenopausal; Vandetanib

Indexed keywords

FULVESTRANT; PLACEBO; TELOPEPTIDE; VANDETANIB; ANTINEOPLASTIC AGENT; COLLAGEN TYPE 1; COLLAGEN TYPE I TRIMERIC CROSS-LINKED PEPTIDE; ESTRADIOL; ESTROGEN RECEPTOR; N-(4-BROMO-2-FLUOROPHENYL)-6-METHOXY-7-((1-METHYLPIPERIDIN-4-YL)METHOXY)QUINAZOLIN-4-AMINE; PEPTIDE; PIPERIDINE DERIVATIVE; PROGESTERONE RECEPTOR; QUINAZOLINE DERIVATIVE; TUMOR MARKER;

ADULT; ARTICLE; BONE METASTASIS; BONE TURNOVER; BREAST CANCER; CANCER PROGNOSIS; CANCER SURVIVAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ESTROGEN RECEPTOR POSITIVE BREAST CANCER; FEMALE; HUMAN; LUNG INFECTION; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; OSTEOLYSIS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN ASSESSMENT; PERICARDITIS; PHASE 2 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; PROGESTERONE RECEPTOR POSITIVE BREAST CANCER; PROGRESSION FREE SURVIVAL; PROTEIN URINE LEVEL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; UNSPECIFIED SIDE EFFECT; AGED; ANALOGS AND DERIVATIVES; BONE NEOPLASMS; BREAST NEOPLASMS; CLINICAL TRIAL; METABOLISM; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; SECONDARY; TREATMENT OUTCOME; URINE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; BREAST NEOPLASMS; COLLAGEN TYPE I; ESTRADIOL; FEMALE; HUMANS; MIDDLE AGED; PEPTIDES; PIPERIDINES; POSTMENOPAUSE; QUINAZOLINES; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84903692358     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-014-3015-6     Document Type: Article

References (32)

1. Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A (2010) Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol 28:5132-5139. doi:10.1200/JCO.2010.29.7101
2. Santini D, Vincenzi B, Hannon RA, Brown JE, Dicuonzo G, Angeletti S, La Cesa A, Coleman RE, Tonini G, Budillon A, Caraglia M, Holen I (2006) Changes in bone resorption and vascular endothelial growth factor after a single zoledronic acid infusion in cancer patients with bone metastases from solid tumours. Oncol Rep 15:1351-1357
3. Amir E, Trinkaus M, Simmons CE, Dranitsaris G, Clemons MJ (2009) Vascular endothelial growth factor activity after switching of bisphosphonate treatment for metastatic breast cancer. J Clin Pathol 62:474-476. doi:10.1136/jcp.2008. 062505
4. Poon RT, Fan ST, Wong J (2001) Clinical implications of circulating angiogenic factors in cancer patients. J Clin Oncol 19:1207-1225 (Pubitemid 32176299)
5. Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JS, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley PL, Hennequin LF (2002) ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res 62:4645-4655
6. Carlomagno F, Vitagliano D, Guida T, Ciardiello F, Tortora G, Vecchio G, Ryan AJ, Fontanini G, Fusco A, Santoro A (2002) ZD6474, an orally available inhibitor of KDR tyrosine kinase activity, efficiently blocks oncogenic RET kinases. Cancer Res 62:7284-7290 (Pubitemid 36025251)
7. Plaza-Menacho I, Morandi A, Robertson D, Pancholi S, Drury S, Dowsett M, Martin LA, Isacke CM (2010) Targeting the receptor tyrosine kinase RET sensitizes breast cancer cells to tamoxifen treatment and reveals a role for RET in endocrine resistance. Oncogene 29:4648-4657. doi:10.1038/onc.2010.209
8. Wang C, Mayer JA, Mazumdar A, Brown PH (2012) The rearranged during transfection/papillary thyroid carcinoma tyrosine kinase is an estrogen-dependent gene required for the growth of estrogen receptor positive breast cancer cells. Breast Cancer Res Treat 133:487-500. doi:10.1007/s10549- 011-1775-9
9. Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD (2011) Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 29:1059-1066. doi:10.1200/JCO.2010.28.5981
10. Wells SA, Robinson BJ, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ (2012) Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol 30:134-141. doi:10.1200/JCO.2011.35.5040
11. Miller KD, Trigo JM, Wheeler C, Barge A, Rowbottom J, Sledge G, Baselga J (2005) A multicenter phase II trial of ZD6474, a vascular endothelial growth factor receptor-2 and epidermal growth factor receptor tyrosine kinase inhibitor, in patients with previously treated metastatic breast cancer. Clin Cancer Res 11:3369-3376 (Pubitemid 40627889)
12. Mayer EL, Isakoff SJ, Klement G, Downing SR, Chen WY, Hannagan K, Gelman R, Winer EP, Burstein HJ (2012) Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics. Breast Cancer Res Treat 36:169-178
13. Boér K, Láng I, Llombart-Cussac A, Andreasson I, Vivanco GL, Sanders N, Pover GM, Murray E (2012) Vandetanib with docetaxel as second-line treatment for advanced breast cancer: a double-blind, placebo-controlled, randomized Phase II study. Invest New Drugs 30:681-687
14. Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, Fein L, Romieu G, Buzdar A, Robertson JF, Brufsky A, Possinger K, Rennie P, Sapunar F, Lowe E, Piccart M (2008) Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 26:1664-1670. doi:10.1200/JCO.2007.13.5822
15. Simmons C, Broom RJ, Cole DE, Dranitsaris G, Clemons M (2007) Urinary N-telopeptide is a rapid predictor of response to and palliative benefit from bisphosphonate therapy in patients with metastatic breast cancer. Support Cancer Ther 4:182-187 (Pubitemid 47606343)
16. Vinholes J, Coleman R, Lacombe D, Rose C, Tubiana-Hulin M, Bastit P, Wildiers J, Michel J, Leonard R, Nortier J, Mignolet F, Ford J (1999) Assessment of bone response to systemic therapy in an EORTC trial: preliminary experience with the use of collagen cross-link excretion. European Organization for Research and Treatment of Cancer. Br J Cancer 80:221-228 (Pubitemid 29210110)
17. Clemons MJ, Dranitsaris G, Ooi WS, Yogendran G, Sukovic T, Wong BY, Verma S, Pritchard KI, Trudeau M, Cole DE (2006) Phase II trial evaluating the palliative benefit of second-line zoledronic acid in breast cancer patients with either a skeletal-related event or progressive bone metastases despite first-line bisphosphonate therapy. J Clin Oncol 24:4895-4900 (Pubitemid 46630917)
18. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
19. Tan G, Jensen MP, Thornby JI, Shanti BF (2004) Validation of the brief pain inventory for chronic nonmalignant pain. J Pain 5:133-137 (Pubitemid 38850184)
20. Broom R, Du H, Clemons M, Eton D, Dranitsaris G, Simmons C, Ooi W, Cella D (2009) Switching breast cancer patients with progressive bone metastases to third generation bisphosphonates: measuring impact using the functional assessment of cancer therapy-bone pain. J Pain Symptom Manag 38:244-257. doi:10.1016/j.jpainsymman.2008.08.005
21. Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Revil C, Jones A (2009) Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol 27:5529-5537. doi:10.1200/JCO.2008.20.6847
22. Baselga J, Campone M, Piccart M, Burris HA, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN (2012) Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. New Engl J Med 366:520-529. doi:10.1056/NEJMoa1109653
23. Gnant M, Baselga J, Rugo HS, Noguchi S, Burris HA, Piccart M, Hortobagyi GN, Eakle J, Mukai H, Iwata H, Geberth M, Hart LL, Hadji P, El-Hashimy M, Rao S, Taran T, Sahmoud T, Lebwohl D, Campone M, Pritchard KI (2013) Effect of everolimus on bone marker levels and progressive disease in bone in BOLERO-2. J Natl Cancer Inst 105:654-663. doi:10.1093/jnci/djt026
24. Osborne CK, Neven P, Dirix LY, Mackey JR, Robert J, Underhill C, Schiff R, Gutierrez C, Migliaccio I, Anagnostou VK, Rimm DL, Magill P, Sellers M (2011) Gefitinib or placebo in combination with tamoxifen in patients with hormone receptorpositive metastatic breast cancer: a randomized phase II study. Clin Cancer Res 17:1147-1159. doi:10.1158/1078-0432
25. Wagner AD, Thomssen C, Haerting J, Unverzagt S (2012) Vascular-endothelial-growth-factor (VEGF) targeting therapies for endocrine refractory or resistant metastatic breast cancer. Cochrane Database Syst Rev 7:008941
26. 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 (2010) 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 28:4594-4600
27. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247
28. Lipton A, Costa L, Coleman RE (2011) Bone turnover markers: tools for prognosis and monitoring response to bisphosphonates? Breast Dis 33:59-69. doi:10.3233/BD-2010-0327
29. Fizazi K, Lipton A, Mariette X, Body JJ, Rahim Y, Gralow JR, Gao G, Wu L, Sohn W, Jun S (2009) Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol 27:1564-1571
30. Amir E, Freedman O, Carlsson L, Dranitsaris G, Tomlinson G, Laupacis A, Tannock IF, Clemons M (2013) Randomized feasibility study of de-escalated (Every 12 wk) versus standard (Every 3 to 4 wk) intravenous pamidronate in women with low-risk bone metastases from breast cancer. Am J Clin Oncol 36:436-442
31. Clemons M, Dranitsaris G, Ooi W, Cole DE (2008) A phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy. Breast Cancer Res Treat 108:79-85 (Pubitemid 351623243)
32. Lipton A, Cook R, Brown J, Body JJ, Smith M, Coleman R (2013) Skeletal-related events and clinical outcomes in patients with bone metastases and normal levels of osteolysis: exploratory analyses. Clin Oncol 25:217-226