Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023
Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed.
- Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial.Nature communications · 2026Trial
- The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the Swedish phase II randomized PREDIX HER2 trial.Breast cancer research and treatment · 2024Trial
- Restoring the CD226 in CD8Cell death & disease · 2026Article
- AI-powered and manual assessment of tumor-infiltrating lymphocytes in early HER2-positive breast cancer in NSABP B-41.NPJ breast cancer · 2026Article
- The role of radiomics in predicting the response to neoadjuvant chemotherapy for breast cancer.Cancer biology & medicine · 2026Review
- Risk Factors for Disease Recurrence in Patients with HER2+ Early Breast Cancer and Implications for Therapy: A Narrative Review.Oncology and therapy · 2026Review
- The landscape of dynamic tumor immunophenotyping on neoadjuvant chemotherapy combined with trastuzumab for the treatment of HER2-positive breast cancer.Molecular cancer · 2025Article
- Survival outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer patients.The oncologist · 2025Article
- Advances in the intrinsic signaling pathway interactions and clinical translation of HR+/HER2+ breast cancer.Breast cancer (Tokyo, Japan) · 2025Review
- Prognostic and recurrence risk predictive values of tumor infiltrating lymphocytes in HER2-low breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
- Omission of anthracyclines from neoadjuvant chemotherapy for breast cancer: a population-based analysis.Breast cancer research and treatment · 2025Article
- Article
- Clinical implications of peripheral blood biomarkers in patients with advanced breast cancer treated with trastuzumab emtansine and trastuzumab deruxtecan.International journal of clinical oncology · 2025Article
- A compositeBreast (Edinburgh, Scotland) · 2025Article
- Multiplex Spatial Proteomic Analysis of HER2-Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response.JCO precision oncology · 2025Article
- Machine learning-based spatial characterization of tumor-immune microenvironment in the EORTC 10994/BIG 1-00 early breast cancer trial.NPJ breast cancer · 2025Article
- The optimal neoadjuvant treatment strategy for HR+/HER2 + breast cancer: a network meta-analysis.Scientific reports · 2025Article
- The analytical and clinical validity of AI algorithms to score TILs in TNBC: can we use different machine learning models interchangeably?EClinicalMedicine · 2024Article
- Antibody drug conjugate, a level-up version of monoclonal antibody?International journal of surgery (London, England) · 2024Article
- Multimodal data integration using machine learning to predict the risk of clear cell renal cancer metastasis: a retrospective multicentre study.Abdominal radiology (New York) · 2024Article
Corrections and comments
- Commented on by
Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePREDIX HER2 is a randomized Phase II trial that compared neoadjuvant docetaxel, trastuzumab, and pertuzumab (THP) with trastuzumab emtansine (T-DM1) for HER2-positive breast cancer. Rates of pathologic complete response (pCR) did not differ between the two groups. Here, we present the survival outcomes from PREDIX HER2 and investigate metabolic response and tumor-infiltrating lymphocytes (TIL) as prognostic factors. PATIENTS AND
methodsIn total, 202 patients with HER2-positive breast cancer were enrolled and 197 patients received six cycles of either THP or T-DM1. Secondary endpoints included event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Assessment with PET/CT was performed at baseline, after two and six treatment cycles. TILs were assessed manually at baseline biopsies, while image-based evaluation of TILs [digital TILs (DTIL)] was performed in digitized full-face sections.
resultsAfter a median follow-up of 5.21 years, there was no difference between the two treatment groups in terms of EFS [HR = 1.26; 95% confidence interval (CI), 0.54-2.91], RFS (HR = 0.69; 95% CI, 0.24-1.93), or OS (HR = 0.52; 95% CI, 0.09-2.82). Higher SUVmax at cycle 2 (C2) predicted lower pCR (ORadj = 0.65; 95% CI, 0.48-0.87; P = 0.005) and worse EFS (HRadj = 1.27; 95% CI, 1.12-1.41; P < 0.001). Baseline TILs and DTILs provided additional prognostic information to clinical parameters and C2 SUVmax.
conclusionsLong-term outcomes following neoadjuvant T-DM1 were similar to neoadjuvant THP. SUVmax after two cycles of neoadjuvant therapy for HER2-positive breast cancer may be an independent predictor of both short- and long-term outcomes. Combined assessment with TILs may facilitate early selection of poor responders for alternative treatment strategies.
Indexed as
Identifiers
36449695What 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.