Breast cancer, ER and HER2 co-expressing
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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
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Metastatic disease, first-line therapy
Anastrozole monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kaufman et al. 2009 (TAnDEM) | 2001-2004 | Phase III (C) | Anastrozole & Trastuzumab | Inferior PFS |
Hormonotherapy
- Anastrozole (Arimidex) 1 mg PO once per day
28-day cycles
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. link to original article contains protocol PubMed NCT00022672
Anastrozole & Trastuzumab
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kaufman et al. 2009 (TAnDEM) | 2001-2004 | Phase III (E-esc) | Anastrozole | Superior PFS |
Hormonotherapy
- Anastrozole (Arimidex) 1 mg PO once per day
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
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. link to original article contains protocol PubMed NCT00022672
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
- Lapatinib (Tykerb) 1500 mg PO once per day
Hormonotherapy
- Letrozole (Femara) 2.5 mg PO once per day
Continued indefinitely
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. 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) | NR-2016 | Phase III (E-esc) | 1. Lapatinib & Letrozole | Not reported |
| 2. Letrozole & Trastuzumab | Superior PFS |
Note: the original article has been retracted and an update has been published.
Targeted therapy
- Lapatinib (Tykerb) 1000 mg PO once per day
- 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
- 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. link to original article contains verified protocol 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. 2020 Aug 21:JCO2001894. Epub ahead of print. link to original article 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
- Letrozole (Femara) 2.5 mg PO once per day
28-day cycles
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. link to original article contains protocol PubMed NCT00073528