ALTTO

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

Phase

Phase 3

Status

Completed

Conditions

Neoplasms, Breast

Interventions

Lapatinib; Trastuzumab

Arms

• Lapatinib plus Trastuzumab · Experimental
• Trastuzumab followed by Lapatinib · Experimental
• Lapatinib · Experimental
• Trastuzumab · Active comparator

Enrollment

8,381

Primary outcomes

• Disease-Free Survival (DFS) at the Primary Analysis

Sponsor

Novartis Pharmaceuticals with North Central Cancer Treatment Group, National Cancer Institute (NCI), Breast International Group, Canadian Cancer Trials Group

Start

May 16, 2007

Primary completion

Dec 6, 2013

Results posted

Yes

Registry record

NCT00490139 · updated Mar 21, 2025

• Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3. PubMed 39613746
• de Azambuja E, Piccart-Gebhart M, Fielding S, Townend J, Hillman DW, Colleoni M, Roylance R, Kelly CM, Lombard J, El-Abed S, Choudhury A, Korde L, Vicente M, Chumsri S, Rodeheffer R, Ellard SL, Wolff AC, Holtschmidt J, Lang I, Untch M, Boyle F, Xu B, Werutsky G, Tujakowski J, Huang CS, Baruch NB, Bliss J, Ferro A, Gralow J, Kim SB, Kroep JR, Krop I, Kuemmel S, McConnell R, Moscetti L, Knop AS, van Duijnhoven F, Gomez H, Cameron D, Di Cosimo S, Gelber RD, Moreno-Aspitia A. Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]. ESMO Open. 2024 Nov;9(11):103938. doi: 10.1016/j.esmoop.2024.103938. Epub 2024 Oct 17. PubMed 39418883
• Nader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1. PubMed 36050448
• Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23. PubMed 33765513
• Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23. PubMed 33152119
• Eiger D, Ponde NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Lang I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16. PubMed 32203207
• Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195. PubMed 31240310
• McCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7. PubMed 24395109