Emerging drugs in metastatic breast cancer: An update

Expert Opinion on Emerging Drugs

Volumn 16, Issue 4, 2011, Pages 647-667

  Arslan, Cagatay ^a   Altundag, Kadri ^b   Dizdar, Omer ^c  

^a Izmir Tepecik Training and Research Hospital   (Turkey)

^b HACETTEPE UNIVERSITY   (Turkey)

^c BASKENT UNIVERSITY   (Turkey)

Author keywords

Biologic agent; Chemotherapy; Metastatic breast cancer; New drugs

Indexed keywords

ANTHRACYCLINE; BRCA1 PROTEIN; CABAZITAXEL; CAPECITABINE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ERIBULIN; ESTROGEN RECEPTOR; FULVESTRANT; GEMCITABINE; GLYCOPROTEIN P INHIBITOR; HORMONE RECEPTOR; IRINOTECAN; IXABEPILONE; LAPATINIB; LETROZOLE; MAMMALIAN TARGET OF RAPAMYCIN; NAVELBINE; OXALIPLATIN; PACLITAXEL; PEMETREXED; PERTUZUMAB; PROGESTERONE RECEPTOR; PROTEIN TYROSINE KINASE INHIBITOR; TAMOXIFEN; TAXANE DERIVATIVE; TRASTUZUMAB; UNINDEXED DRUG;

BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CARDIOTOXICITY; DIARRHEA; DISEASE COURSE; FATIGUE; FEBRILE NEUTROPENIA; HAND FOOT SYNDROME; HUMAN; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; PERIPHERAL NEUROPATHY; REVIEW; VISCERAL METASTASIS;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; DRUGS, INVESTIGATIONAL; FEMALE; HUMANS; NEOPLASM METASTASIS; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 84555190252     PISSN: 14728214     EISSN: None     Source Type: Journal    
DOI: 10.1517/14728214.2011.640672     Document Type: Review

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116. Gradishar WJ, Kaklamani V, Prasad Sahoo T, et al. A double-blind, placebo-controlled, phase IIb, study evaluating the efficacy and safety of sorafenib in combination with paclitaxel as a first-line therapy in patients with locally recurrent or metastatic breast cancer abstract 44. 2009 San Antonio Breast Cancer Symposium
117. Baselga J, Roche H, Costa F, et al. SOLTI-0701: A multinational double-blind, randomized phase IIb study evaluating the efficacy and safety of sorafenib compared to placebo when adminestered in combination with capecitabine in patients with locally advanced or metastatic breast cancer abstract 45. 2009 San Antonio Breast Cancer Symposium
118. Bondarde S, Kaklamani V, Prasad Sahoo T, et al. Sorafenib in combination with paclitaxel as a first-line therapy in patients with locally recurrent or metastatic breast cancer: OS results from a double-blind, randomized, placebo-controlled, phase IIb trial abstract P2-16-03. 2010 San Antonio Breast Cancer Symposium
119. Isaacs C, Herbolsheimer P, Liu MC, et al. Phase I/II study of sorafenib with anastrozole in patients with hormone receptor positive aromatase inhibitor resistant metastatic breast cancer. Breast Cancer Res Treat 2011;125:137-43
120. Tan A, Reiss S, Wong S, et al. Letrozole and sorafenib as first-line therapy in postmenopausal women with hormone receptor-positive metastatic breast cancer: preliminary results abstract 256. 2009 ASCO Breast Cancer Symposium
121. Isaacs C, Wilkinson M, Liu MC, et al. Phase II study of sorafenib with anastrozole to overcome resistance to aromatase inhibitor (AI)s in patients with hormone receptor positive (ER/PR+) AI resistant metastatic braest cancer abstract 6093. 2009 San Antonio Breast Cancer Symposium
122. Rugo HS, Stopeck A, Joy AA, et al. A randomized double blind phase II study of the oral tyrosine kinase inhibitor (TKI) axitinib (AG 013736) in combination with docetaxel (DOC) compared to DOC plus placebo (PL) in metastatic breast cancer (MBC). J Clin Oncol 2007;25:abstract 1003
123. Miller KD, Trigo JM, Wheeler C, et al. 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 2005;11:3369-76 (Pubitemid 40627889)
124. Slamon D, Gomez HL, Kabbinavar FF, et al. Randomized study of pazopanib plus lapatinib versus lapatinib alone in patients with HER2-positive advanced or
125. Krop IE, Beeram M, Modi S, et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 2010;28:2698-704
126. Isakoff SJ, Baselga J. Trastuzumab-DM1: building a chemotherapy-free road in the treatment of human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2011;29:351-4
127. Hurvitz S, Dirix L, Kocsis J, et al. Trastuzumab emtansine (T-DM1) versus trastuzumab plus docetaxel in previously untreated HER2-positive metastatic breast cancer abstract 5001. ECCO-ESMO 2011
128. Baselga J, Swain SM. CLEOPATRA: a phase III evaluation of pertuzumab and trastuzumab for HER2-positive metastatic breast cancer. Clin Breast Cancer 2010;10:489-91
129. Gianni L, Llado A, Bianchi G, et al. Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of Pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010;28:1131-7
130. Baselga J, Gelmon KA, Verma S, et al. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol 2010;28:1138-44
131. Portera CC, Walshe JM, Rosing DR, et al. Cardiac toxicity and efficacy of trastuzumab combined with pertuzumab in patients with corrected human epidermal growth factor receptor 2-positive metastatic breast cancer. Clin Cancer Res 2008;14:2710-16
132. Baselga J, Cortes J, Fumoleau P, et al. Pertuzumab and trastuzumab: Re-responses to 2 biological agents in patients with HER2-positive breast cancer which had previously progressed during therapy with agent given separately: a new biological and clinical observation abstract 5114. 2009 San Antonio Breast Cancer Symposium
133. Dieras V, Harbeck N, Albain K, et al. A Phase Ib/II trial of trastuzumab with pertuzumab for patients with HER2-positive, locally advanced or metastatic breast cancer: Inetrim efficacy and safety results abstract P3-14-01. 2010 San Antonio Breast Cancer Symposium
134. Dickler MN, Cobleigh MA, Miller KD, et al. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat 2009;115:115-21
135. Britten CD, Finn RS, Bosserman LD, et al. A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach. Clin Breast Cancer 2009;9:16-22
136. Twelves C, Trigo JM, Jones R, et al. Erlotinib in combination with capecitabine and docetaxel in patients with metastatic breast cancer: a dose-escalation study. Eur J Cancer 2008;44:419-26
137. Schuler MH, Uttenreuther-Fischer MM, Piccart-Gebhart MJ, Harbeck N. BIBW 2992, a novel irreversible EGFR/HER1 and HER2 tyrosine kinase inhibitor, for the treatment of patients with HER2-negative metastatic breast cancer after failure of no more than two prior chemotherapies abstract 1065. 2010 ASCO Annual Meeting
138. Hickish T, Wheatlery D, Lin N, et al. Use of BIBW 2992, a novel irreversible EGFR/HER1 and HER2 tyrosine kinase inhibitor to treat patients with HER2-positive metastatic breast cancer after failure of treatment with trastuzumab abstract 5060. 2009 San Antonio Breast Cancer Symposium
139. Harbeck N, Schmidt M, Harter P, et al. BIBW 2992, a novel irreversibl EGFR/HER1 and HER2 tyrosine kinase inhibitor for the treatment of patients with HER2-negative metastatic breast cancer after failure of no more than two prior chemotherapies abstract 5062. 2009 San Antonio Breast Cancer Symposium
140. Gunzer K, Joly F, Deloizer T, et al. Addition of BIBW 2992, an irreversible inhibitor of EGFR/HER1 and HER2 inhibitor, to treatment continuation of letrozole in estrogen receptor positive metastatic breast cancer progressing on letrozole abstract 4098. 2009 San Antonio Breast Cancer Symposium
141. Starolawska E, Dirix L, Luu T, et al. Safety and efficacy of neratinib plus vinorelbine in the treatment of patients with ErbB2+ metastatic breast cancer pretreated with Anti-HER2 therapy abstract P3-14-08. 2010 San Antonio Breast Cancer Symposium
142. Awada A, Dirix L, Beck J, et al. Safety and efficacy of neratinib (HKI-272) in combination with vinorelbine in ErbB2+ metastatic breast cancer abstract 5095. 2009 San Antonio Breast Cancer Symposium
143. Chow L, Gupta S, Hershman D, et al. Safety and efficacy of neratinib (HKI-272) in combination with paclitaxel in ErbB2+ metastatic breast cancer abstract 5081. 2009 San Antonio Breast Cancer Symposium
144. Tutt A, Robson M, Garber JE, et al. 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;376:235-44
145. O'Shaughnessy J, Osborne C, Pippen JE, et al. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med 2011;364:205-14
146. Moulder S, Mita M, Bradley C, et al. A phase Ib study to assess the safety and tolerability of the PARP inhibitor iniparib (BSI-201) in combination with irinotecan for the treatment of patientss with metastatic breast cancer abstract P6-15-01. 2010 San Antonio Breast Cancer Symposium
147. Zhang J, Zhang XB, Liu JJ, et al. Effects of an mTOR inhibitor RAD001 on human breast cancer stem cells in vitro abstract PD02-09. 2010 San Antonio Breast Cancer Symposium
148. Ellard SL, Clemons M, Gelmon KA, et al. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol 2009;27:4536-41
149. Chen CS, Chen MM, Imaoka RT, et al. A Phase I pilot study of the oral mTOR inhibitor RAD001in combination with capecitabine for metastatatic breast cancer abstract 6112. 2009 San Antonio Breast Cancer Symposium
150. Jerusalem G, Fasolo A, Dieras V, et al. Phase I trial of oral mTOR inhibitor everolimus in combination with trastuzumab and vinorelbine in pre-treated patients with HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat 2011;125:447-55
151. Morrow PK, Wulf GM, Ensor J, et al. Phase I/II study of trastuzumab in combination with everolimus (RAD001) in patients with HER2-overexpressing metastatic breast cancer who progressed on trastuzumab-based therapy. J Clin Oncol 2011;29:3126-32
152. Cardoso F, Dieras V, Campone M, et al. Eveolimus (Afinitor®) trastuzumab, and paclitaxel or vinorelbine in the treatment of HER-2 positive metastatic breast cancer patients pre-treated with lapatinib-containing therapy: pooled analysis of 2 phase I studies abstract 5064. 2009 San Antonio Breast Cancer Symposium
153. Andre F, Campone M, O'Regan R, et al. Phase I study of everolimus plus weekly paclitaxel and trastuzumab in patients with metastatic breast cancer pretreated with trastuzumab. J Clin Oncol 2010;28:5110-15
154. Mayer IA, Burris HA, Bendell JC, et al. A phase Ib trial of RAD001, an mTOR inhibitor, with weekly cisplatin and paclitaxel in patients with HER2-negative metastatic breast cancer abstract 3093. 2009 San Antonio Breast cancer Symposium
155. Jerusalem GH, Fasolo A, Massacesi C, et al. Maintenance with everolimus (RAD001) and trastuzumab after discontinuation of chemotherapy in patients with heavily pretreated HER2-positive metastatic breast cancer: pooled data of extension cohorts of phase Ib/II studies abstract 1041. 2010 ASCO Annual Meeting
156. Baselga J, Campone M, Piccart-Gebhart MJ, et al. Everolimus in combination with exemestane in the treatment of postmenopausal women with estrogen receptor-positive metastatic breast cancer who are refractory to letrozole or anastrozole: preliminary results of the BOLERO-2 trial abstract e11058. 2011 ASCO Annual Meeting
157. Bachelot T, Bourgier C, Cropet C, et al. TAMRAD: A GINECO randomized phase II trial of everolimus in combination with tamoxifen versus tamoxifen alone in patients with hormone receptor positive, HER2-negative metastatic breast cancer with prior exposure to aromatase inhibitors abstract S1-6. 2010 San Antonio Breast Cancer Symposium
158. Badin F, Romond E, Chambers M, et al. A phase II trial of fulvestrant and RAD001 (everolimus) in patients with metastatic estrogen receptor positive breast cancer after aromatase inhibitor failure, a study in progress abstract P4-02-05. 2010 San Antonio Breast Cancer Symposium
159. Baselga J, Campone M, Piccart-Gebhart MJ, et al. Everolimus in combination with exemestane in the treatment of postmenopausal women with estrogen receptor-positive metastatic breast cancer who are refractory to letrozole or anastrozole: preliminary results of the BOLERO-2 trial abstract 9LBA. ECCO-ESMO 2011
160. Jerusalem G, Ellard SL, Fasolo A, et al. Non-infectious pneumonitis in breast cancer patients treated with everolimus (Afinitor®) containing therapy: analysis of five studies abstract 1115. 2009 San Antonio Breast Cancer Symposium
161. Chan S, Scheulen ME, Johnston S, et al. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol 2005;23:5314-22 (Pubitemid 46206985)
162. Carpenter JT, Roche H, Campone M, et al. Randomized phase 3 arm, phase 2 study of temsirolimus (CCI-7702) in combination with letrozole in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol 2005;23:abstract 564
163. Peacock NW, Jones SF, Yardley DA, et al. The safety and tolerability of panobinostat in combination with capecitabine +/-lapatinib. A phase I study in HER+ breast cancer abstract 1115. 2010 ASCO Annual Meeting
164. Campone M, Conte P, Amodori D, et al. Phase I trial of panobinostat (LBH589) in combination with trastuzumab in pretreated HER2-positive metastatic breast cancer: preliminary safety, efficacy and pharmacocinetic results abstract 6101. 2009 San Antonio Breast Cancer Symposium
165. Swaby RF, Wang M, Sparano JA, et al. A phase II study of histone deacetylase inhibitor vorinostat, in combination with trastuzumab in patients with advanced metastatic and/or local chest wall recurrent Her-2 amplified breast cancer resistant to trastuzumab-containing therapy: (E1104) a trial of the Eastern Cooperative Oncology Group abstract 793. 2009 San Antonio Breast Cancer Symposium
166. Munster PN, Lacevic M, Thomas S, et al. Clinical phase II study of vorinostat, a hydoxamic type histone deacetylase inhibitor, in combination with tamoxifen tor everse acquired hotmone resistance in breast cancer patients who preogressed on hormone therapy abstract 6100. 2009 San Antonio Breast Cancer Symposium
167. Wardley AM, McCaffrey J, Crown J, et al. Preliminary phase II data suggest that entinostat (SNDX275), a class 1 selective histone deacetylase inhibitor, may resensitize breast cancer patients progressing on aromatase inhibitor (AI) therapy to their AI therapy abstract 6111. 2009 San Antonio Breast cancer Symposium
168. Chen D, Frezza M, Schmitt S, et al. Bortezomib as the first proteasome inhibitor anticancer drug: current status and future perspectives. Curr Cancer Drug Targets 2011;11:239-53
169. Irvin WJ Jr, Orlowski RZ, Chiu WK, et al. Phase II study of bortezomib and pegylated liposomal doxorubicin in the treatment of metastatic breast cancer. Clin Breast Cancer 2010;10:465-70
170. Awada A, Albanell J, Canney PA, et al. Bortezomib/docetaxel combination therapy in patients with anthracycline-pretreated advanced/metastatic breast cancer: a phase I/II dose-escalation study. Br J Cancer 2008;98:1500-7 (Pubitemid 351652337)
171. Schmid P, Kuhnhardt D, Kiewe P, et al. A phase I/II study of bortezomib and capecitabine in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines. Ann Oncol 2008;19:871-6 (Pubitemid 351627300)
172. Trinh XB, Sas L, Laere V, et al. A phase II study of the combination of endocrine treatment and bortezomib in patients with endocrine-resistant metastatic breast cancer abstract e11072. 2011 ASCO Annual Meeting
173. Schroder CP, Pedersen JV, Chua S, et al. Use of biomarkers and imaging to evaluate the treatment effect of AUY922, an HSP90 inhibitor, in patients with HER2+ or ER+ metastatic breast cancer abstract e11024. 2011 ASCO Annual Meeting
174. Modi S, Ismail-Khan R, Munster P, et al. Phase I dose-escalation study of the heat shock protein 90 inhibitor BIIB021 with trastuzumab in Her2+ metastatic breast cancer abstract P3-14-02. 2010 San Antonio Breast Cancer Symposium
175. Ismail-Khan RR, Marichion DC, Cubitt CL, Jancaster JM. Synergy of ixabepilone and dasatinib in trpile negative breast cancer cell lines abstract P6-15-17. 2010 San Antonio Breast cancer Symposium
176. Morris PG, Abbruzzi A, D'andrea G, et al. A phase I-II trial of dasatinib in combination with weekly paclitaxel for patients with metastatic breast carcinoma abstract P612-09. 2010 San Antonio Breast Cancer Symposium
177. Lipton A, Steger GG, Figueroa J, et al. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res 2008;14:6690-6
178. Stopeck AT, Lipton A, Body JJ, et al. 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 2010;28:5132-9
179. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol 2011;29:1125-32
180. Rugo HS, Stopeck A, Joy AA, et al. Randomized, double-blind phase II study of axitinib plus docetaxel versus docetaxel plus placebo in patients with metastatic breast cancer (MBC). J Clin Oncol 2011;29:2459-65
181. de Boer RH, Kaufman PA, White S, et al. Primary analysis of a phase Ib combination study of motesanib (AMG 706) with paclitaxel or docetaxel for the treatment of locally recurrent, unresectable or metastatic breast cancer. 2009 San Antonio Breast cancer Symposium. Abstract Number: 205
182. Dalenc F, Doisneau-Sixou SF, Allal BC, et al. Tipifarnib plus tamoxifen-resistant metastatic breast cancer: a negative phase II and screening of potential therapeutic markers by proteomic analysis. Clin Cancer Res 2010;16:1264-71
183. Cristofanilli M, Valero V, Mangalik A, et al. Phase II, randomized trial to compare anastrozole combined with gefitinib or placebo in postmenopausal women with hormone receptor-positive metastatic breast cancer. Clin Cancer Res 2010;16:1904-14
184. Britten CD, Finn RS, Bosserman LD, et al. A phase I/II trail of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach. Clin Breast Cancer 2009;9:16-22
185. Chew HK, Barlow WE, Albain K, et al. A phase II study of imatinib mesylate and capecitabine in metastatic breast cancer. Southwest Oncology Group Study 0338. Clin Breast Cancer 2008;8:511-15
186. Mayer EL, Scheulen M, Beckman J, et al. Combination of Tivozanib, an oral inhibitor of VEGFR, with weekly pacliytaxel for metastatic breast cancer: Preliminary results of an ongoing phase I study. 2010 San Antonio Breast cancer Symposium. Abstract Number: P2-16-10
187. Baselga J, Stemmer S, Pego A, et al. Cetuximab+ cisplatin in estrogen receptor-negative, progesterone receptor-negative, HER2-negative (Triple-negative) metastatic breast cancer: Results of the ramdomized phase II BALI-1 Trial. 2010 San Antonio Breast cancer Symposium. Abstract Number: PD01-01
188. Holden SN, Beeram M, Krop IE, et al. A phase I study of weekly dosing of Trastuzumab-DM1 (T-DM1) in Patients with advanced HER2+ breast cancer. 2008 ASCO Annual Meeting. Abstract Number: 1029
189. Yardley DA, Seiler M, Ray-Coquard I, et al. Ridaforolimus (AP23573; MK-8669) in combination with trastuzumab for patients with HER2-positive trastuzumab-refractory metastatic breast cancer: A multicenter phase 2 clinical trial. 2009 San Antonio Breast cancer Symposium. Abstract Number: 3091
190. Miller K, Ng C, Ang P, et al. Phase II, Open label study of ispinesib in patients with locally advanced or metastatic breast cancer. 2005 San Antonio Breast Cancer Symposium. Abstract Number: 1089
191. Barton JH, Shih KC, Raefsky E, et al. Amrubicin as second-or third-line treatment for patients with HER2-negative etastatic breast cancer (MBC: A Sarah Cannon Research Institute phase I trial. 2011 SCO Annual Meeting Abstract No 1116
192. Ramaswamy B, Mrozek E, Kuebler JP, et al. Phase II trial of pyrazoloacridine NSC-66140) in patients with metasttic breast cancer. Invest New Drugs 2011;29:347-51
193. Chia S, Dent S, Ellard S, et al. Phase II trial of OGX-011 in combination with docetaxel in metastatic breast cancer. Clin Cancer Res 2009;15:708-13
194. Slamon D, Gomez HL, Kabbinavar FF, et al. Randomized study of pazopanib + lapatinib vs. lapatinib alone in patients with HER2-positive advanced or metastatic breast cancer. 2008 ASCO Annual Meeting. Abstract Number: 1016
195. Campone M, Dittrich C, Cufer T, et al. Phase II study of the novel epothilone sagopilone (ZK-EPO) in patients with progressive metastatic breast cancer. 2009 San Antonio Breast cancer Symposium. Abstract Number: 6107
196. Yardley DA, Mcleod M, Schreiber F, et al. A Phase II trial of vinflunine as monotherapy or in combination with trastuzumab with trastuzumab as first-line treatment of metastatic breast cancer. Cancer Inve
197. Awada A, Albanell J, Canney PA, et al. Bortezomib/docetaxel combination therapy in patients with anthracycline-pretreated advanced/metastatic breast cancer: a phase I/II dose escalation study. Br J Cancer 2008;98:1500-7 (Pubitemid 351652337)
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