Difference between revisions of "Breast cancer, ER and HER2 co-expressing"

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|[[#top|back to top]]
 
|[[#top|back to top]]
 
|}
 
|}
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===Regimen {{#subobject:e6f8f0|Variant=1}}===
+
===Regimen variant #1, weekly trastuzumab {{#subobject:e6f8f0|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
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'''28-day cycles'''
 
'''28-day cycles'''
 +
 +
===Regimen variant #2, q3wk trastuzumab {{#subobject:ugibx4|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|rowspan=2|[https://doi.org/10.1200/jco.20.01894 Johnston et al. 2020 (ALTERNATIVE)]
 +
|rowspan=2|2011-2016
 +
|rowspan=2 style="background-color:#1a9851"|Phase III (C)
 +
|1. Anastrozole & Lapatinib<br> 2. Exemestane & Lapatinib<br> 3. [[#Lapatinib_.26_Letrozole|Lapatinib & Letrozole]]
 +
| style="background-color:#d3d3d3" |Not reported
 +
|-
 +
|4. [[#Anastrozole.2C_Lapatinib.2C_Trastuzumab|Anastrozole, Lapatinib, Trastuzumab]]<br> 5. [[#Exemestane.2C_Lapatinib.2C_Trastuzumab|Exemestane, Lapatinib, Trastuzumab]]<br> 6. [[#Lapatinib.2C_Letrozole.2C_Trastuzumab|Lapatinib, Letrozole, Trastuzumab]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
''Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.''
 +
====Targeted therapy====
 +
*[[Trastuzumab (Herceptin)]] as follows:
 +
**Cycle 1: 8 mg/kg IV once on day 1
 +
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 +
====Hormonotherapy====
 +
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
 +
 +
'''21-day cycles'''
  
 
===References===
 
===References===
 
# '''TAnDEM:''' Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. 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. 2009 Nov 20;27(33):5529-37. Epub 2009 Sep 28. [https://doi.org/10.1200/JCO.2008.20.6847 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19786670 PubMed] NCT00022672
 
# '''TAnDEM:''' Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. 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. 2009 Nov 20;27(33):5529-37. Epub 2009 Sep 28. [https://doi.org/10.1200/JCO.2008.20.6847 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19786670 PubMed] NCT00022672
 +
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 +
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
  
 
==Anastrozole, Lapatinib, Trastuzumab {{#subobject:gg0dbc|Regimen=1}}==
 
==Anastrozole, Lapatinib, Trastuzumab {{#subobject:gg0dbc|Regimen=1}}==
Line 104: Line 134:
 
===References===
 
===References===
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
−
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
+
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
 +
 
 +
==Exemestane & Trastuzumab {{#subobject:ugjxbc|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:1yga84|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|rowspan=2|[https://doi.org/10.1200/jco.20.01894 Johnston et al. 2020 (ALTERNATIVE)]
 +
|rowspan=2|2011-2016
 +
|rowspan=2 style="background-color:#1a9851"|Phase III (C)
 +
|1. Anastrozole & Lapatinib<br> 2. Exemestane & Lapatinib<br> 3. [[#Lapatinib_.26_Letrozole|Lapatinib & Letrozole]]
 +
| style="background-color:#d3d3d3" |Not reported
 +
|-
 +
|4. [[#Anastrozole.2C_Lapatinib.2C_Trastuzumab|Anastrozole, Lapatinib, Trastuzumab]]<br> 5. [[#Exemestane.2C_Lapatinib.2C_Trastuzumab|Exemestane, Lapatinib, Trastuzumab]]<br> 6. [[#Lapatinib.2C_Letrozole.2C_Trastuzumab|Lapatinib, Letrozole, Trastuzumab]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
''Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.''
 +
====Targeted therapy====
 +
*[[Trastuzumab (Herceptin)]] as follows:
 +
**Cycle 1: 8 mg/kg IV once on day 1
 +
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 +
====Hormonotherapy====
 +
*[[Exemestane (Aromasin)]] 1 mg PO once per day
 +
 
 +
'''21-day cycles'''
 +
===References===
 +
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 +
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
  
 
==Exemestane, Lapatinib, Trastuzumab {{#subobject:hh0dbc|Regimen=1}}==
 
==Exemestane, Lapatinib, Trastuzumab {{#subobject:hh0dbc|Regimen=1}}==
Line 142: Line 208:
 
===References===
 
===References===
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
−
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
+
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
  
 
==Lapatinib & Letrozole {{#subobject:5fba83|Regimen=1}}==
 
==Lapatinib & Letrozole {{#subobject:5fba83|Regimen=1}}==
Line 210: Line 276:
 
===References===
 
===References===
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
−
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
+
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
  
 
==Letrozole monotherapy {{#subobject:75d541|Regimen=1}}==
 
==Letrozole monotherapy {{#subobject:75d541|Regimen=1}}==
Line 238: Line 304:
 
===References===
 
===References===
 
# '''EGF30008:''' Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. Epub 2009 Sep 28. [https://doi.org/10.1200/JCO.2009.23.3734 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19786658 PubMed] NCT00073528
 
# '''EGF30008:''' Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. Epub 2009 Sep 28. [https://doi.org/10.1200/JCO.2009.23.3734 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/19786658 PubMed] NCT00073528
 +
 +
==Letrozole & Trastuzumab {{#subobject:8ugz41|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:6cq284|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|rowspan=2|[https://doi.org/10.1200/jco.20.01894 Johnston et al. 2020 (ALTERNATIVE)]
 +
|rowspan=2|2011-2016
 +
|rowspan=2 style="background-color:#1a9851"|Phase III (C)
 +
|1. Anastrozole & Lapatinib<br> 2. Exemestane & Lapatinib<br> 3. [[#Lapatinib_.26_Letrozole|Lapatinib & Letrozole]]
 +
| style="background-color:#d3d3d3" |Not reported
 +
|-
 +
|4. [[#Anastrozole.2C_Lapatinib.2C_Trastuzumab|Anastrozole, Lapatinib, Trastuzumab]]<br> 5. [[#Exemestane.2C_Lapatinib.2C_Trastuzumab|Exemestane, Lapatinib, Trastuzumab]]<br> 6. [[#Lapatinib.2C_Letrozole.2C_Trastuzumab|Lapatinib, Letrozole, Trastuzumab]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
''Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.''
 +
====Targeted therapy====
 +
*[[Trastuzumab (Herceptin)]] as follows:
 +
**Cycle 1: 8 mg/kg IV once on day 1
 +
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 +
====Hormonotherapy====
 +
*[[Letrozole (Femara)]] 2.5 mg PO once per day
 +
 +
'''21-day cycles'''
  
 
===References===
 
===References===
 +
<!--- # '''RETRACTED:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. Epub 2017 Dec 15. [https://doi.org/10.1200/JCO.2017.74.7824 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/29244528 PubMed] -->
 +
# '''ALTERNATIVE:''' Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01894 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32822287 PubMed] NCT01160211
 +
 
[[Category:Breast cancer regimens]]
 
[[Category:Breast cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Malignant breast neoplasm]]
 
[[Category:Malignant breast neoplasm]]

Revision as of 03:09, 14 February 2021

Section editor transclusions Note: these are regimens tested in patients with hormone receptor-positive, HER2-positive breast cancer. Please see the main breast cancer page, ER+ breast cancer page, and HER2+ breast cancer page for other regimens.

19 regimens on this page
21 variants on this page


Metastatic disease, first-line therapy

Anastrozole monotherapy

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Kaufman et al. 2009 (TAnDEM) 2001-2004 Phase III (C) Anastrozole & Trastuzumab Inferior PFS

Hormonotherapy

28-day cycles

References

  1. TAnDEM: Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. 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. 2009 Nov 20;27(33):5529-37. Epub 2009 Sep 28. link to original article contains protocol PubMed NCT00022672

Anastrozole & Trastuzumab

back to top

Regimen variant #1, weekly trastuzumab

Study Years of enrollment Evidence Comparator Comparative Efficacy
Kaufman et al. 2009 (TAnDEM) 2001-2004 Phase III (E-esc) Anastrozole Superior PFS

Hormonotherapy

Targeted therapy

  • Trastuzumab (Herceptin) as follows:
    • Cycle 1: 4 mg/kg IV once on day 1, then 2 mg/kg IV once per day on days 8, 15, 22
    • Cycle 2 onwards: 2 mg/kg IV once per day on days 1, 8, 15, 22

28-day cycles

Regimen variant #2, q3wk trastuzumab

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (C) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole, Lapatinib, Trastuzumab
5. Exemestane, Lapatinib, Trastuzumab
6. Lapatinib, Letrozole, Trastuzumab 		Inferior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. TAnDEM: Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. 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. 2009 Nov 20;27(33):5529-37. Epub 2009 Sep 28. link to original article contains protocol PubMed NCT00022672
  2. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211

Anastrozole, Lapatinib, Trastuzumab

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (E-esc) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole & Trastuzumab
5. Exemestane & Trastuzumab
6. Letrozole & Trastuzumab 		Superior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211

Exemestane & Trastuzumab

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (C) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole, Lapatinib, Trastuzumab
5. Exemestane, Lapatinib, Trastuzumab
6. Lapatinib, Letrozole, Trastuzumab 		Inferior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211

Exemestane, Lapatinib, Trastuzumab

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (E-esc) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole & Trastuzumab
5. Exemestane & Trastuzumab
6. Letrozole & Trastuzumab 		Superior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211

Lapatinib & Letrozole

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2009 (EGF30008) 2003-2006 Phase III (E-RT-esc) Letrozole Seems to have superior PFS

Targeted therapy

Hormonotherapy

Continued indefinitely

References

  1. EGF30008: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. Epub 2009 Sep 28. link to original article contains protocol PubMed NCT00073528

Lapatinib, Letrozole, Trastuzumab

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (E-esc) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole & Trastuzumab
5. Exemestane & Trastuzumab
6. Letrozole & Trastuzumab 		Superior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211

Letrozole monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2009 (EGF30008) 2003-2006 Phase III (C) Lapatinib & Letrozole Seems to have inferior PFS

Hormonotherapy

28-day cycles

References

  1. EGF30008: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. Epub 2009 Sep 28. link to original article contains protocol PubMed NCT00073528

Letrozole & Trastuzumab

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Johnston et al. 2020 (ALTERNATIVE) 2011-2016 Phase III (C) 1. Anastrozole & Lapatinib
2. Exemestane & Lapatinib
3. Lapatinib & Letrozole 		Not reported
4. Anastrozole, Lapatinib, Trastuzumab
5. Exemestane, Lapatinib, Trastuzumab
6. Lapatinib, Letrozole, Trastuzumab 		Inferior PFS

Note: the original article published in 2018 was retracted due to numeric errors in the analysis, and an update has been published.

Targeted therapy

Hormonotherapy

21-day cycles

References

  1. ALTERNATIVE: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. Epub 2020 Aug 21. link to original article contains verified protocol PubMed NCT01160211
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