Trial reportEuropean journal of cancer (Oxford, England : 1990)2021
Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).
Trial report in European journal of cancer (Oxford, England : 1990), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00490139 (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), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Lapatinib and lapatinib plus trastuzumab therapy versus trastuzumab therapy for HER2 positive breast cancer patients: an updated systematic review and meta-analysis.Systematic reviews · 2022Pooled it
- 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.British journal of cancer · 2022Trial
- Risk Factors for Disease Recurrence in Patients with HER2+ Early Breast Cancer and Implications for Therapy: A Narrative Review.Oncology and therapy · 2026Review
- Towards precision therapy in HER2-positive early-stage breast cancer.Breast (Edinburgh, Scotland) · 2025Article
- Postoperative radiotherapy improves long-term survival in HER2-positive metastatic breast cancer: real-world evidence from the latest SEER database.Breast cancer research and treatment · 2025Article
- HER2-Positive Breast Cancer Treatment and Resistance.Advances in experimental medicine and biology · 2025Review
- Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial.Nature communications · 2024Article
- Dual HER2 inhibition: mechanisms of synergy, patient selection, and resistance.Nature reviews. Clinical oncology · 2024Review
- Is HER2-Low a New Clinical Entity or Merely a Biomarker for an Antibody Drug Conjugate?Oncology and therapy · 2024Article
- The impact of erythropoiesis-stimulating agents administration concomitantly with adjuvant anti-HER2 treatments on the outcomes of patients with early breast cancer: a sub-analysis of the ALTTO study.Breast cancer research and treatment · 2024Article
- Appraisal of Systemic Treatment Strategies in Early HER2-Positive Breast Cancer-A Literature Review.Cancers · 2023Review
- Reply to: PREDICT underestimates survival of patients with HER2-positive early-stage breast cancer.NPJ breast cancer · 2023Article
- PREDICT underestimates survival of patients with HER2-positive early-stage breast cancer.NPJ breast cancer · 2022Article
- How to Optimise Extended Adjuvant Treatment with Neratinib for Patients with Early HER2+ Breast Cancer.Oncology and therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 20 institutions in 14 countries.
Funding
Abstract
aimTo present the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial. PATIENTS AND
methods8381 patients with stage I-III HER2 positive breast cancer randomised to chemotherapy plus 1-year of trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib + trastuzumab (L+T). The primary endpoint was disease-free survival (DFS). A secondary analysis examined DFS treatment effects by hormone receptor status, nodal status and chemotherapy timing; time to recurrence; overall survival (OS) and safety (overall and cardiac).
resultsAt a median follow-up of 6.9 years, 705 DFS events for L+T versus T were observed. Hazard Ratio (HR) for DFS was 0.86 (95% CI, 0.74-1.00) for L+T versus T and 0.93 (95% CI, 0.81-1.08) for T→L versus T. The 6-year DFS were 85%, 84%, and 82% for L+T, T→L, and T, respectively. HR for OS was 0.86 (95% CI, 0.70-1.06) for L+T versus T and 0.88 (95% CI, 0.71-1.08) for T→L versus T. The 6-year OS were 93%, 92%, and 91% for L+T, T→L, and T, respectively. Subset analyses showed a numerically better HR for DFS in favour of L+T versus T for the hormone-receptor-negative [HR 0.80 (95% CI, 0.64-1.00; 6-yr DFS% = 84% versus 80%)] and the sequential chemotherapy [HR 0.83 (95% CI, 0.69-1.00; 6-yr DFS% = 83% versus79%)] subgroups.
conclusionT+L did not significantly improve DFS and OS over T alone, both with chemotherapy, and, therefore, cannot be recommended for adjuvant treatment of early-stage HER2-positive breast cancer.
trial registrationclinicaltrials.gov Identifier NCT00490139.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.