Trial reportBreast cancer research : BCR2023
Tumor biomarkers and efficacy in patients treated with trastuzumab emtansine + pertuzumab versus standard of care in HER2-positive early breast cancer: an open-label, phase III study (KRISTINE).
Trial report in Breast cancer research : BCR, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02131064 (A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer), which is not on this map. Cited by 30 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.
A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer
Who cites it
30 citing papers in PubMed, 42 citations in OpenAlex.
- Pathologic Complete Response (pCR) Rate and Predictors of Response to Taxane, Trastuzumab, and Pertuzumab in HER2‑Positive Breast Cancer: Secondary Analyses of EA1181/CompassHER2 pCR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Trial
- Neoadjuvant-adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial.Nature communications · 2024Trial
- Right-sizing treatment for HER2-positive breast cancer: evolving algorithms across the disease continuum.Nature reviews. Clinical oncology · 2026Review
- Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- High levels of circulating miR-19a-3p in patients with metastatic HER2 + breast cancer are associated with a favorable prognosis and anti-tumor immune responses.Breast cancer research : BCR · 2026Article
- Factors associated with neoadjuvant therapy insensitivity and its prognostic impact in HER2-positive breast cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2025Article
- Characterisation of mAb104 Antibody-Drug Conjugates Targeting a Tumour-Selective HER2 Epitope.Cancers · 2025Article
- De-escalated neoadjuvant nab-paclitaxel combined with pyrotinib and trastuzumab in intrinsic HER2-enriched breast cancer (NJMU-BC01): a multicenter, single-arm, phase 2 trial.EClinicalMedicine · 2025Article
- Exploring immune activation patterns in HER2-low and HER2-ultralow breast cancer subtypes.The oncologist · 2025Article
- Long Durable Response With Trastuzumab Deruxtecan Monotherapy in a Triple-Negative Metastatic Breast Cancer Patient With Human Epidermal Growth Factor Receptor 2 Mutation: A Long-Term Follow-Up and Literature Review.Journal of medical cases · 2025Article
- Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.Journal of hematology & oncology · 2025Review
- SNX10 deficiency impairs sensitivity to anti-HER2 antibody-drug conjugates via altering HER2 trafficking in HER2-positive breast cancer.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Prognostic value of adjuvant chemotherapy for hormone receptor-negative T1a and T1bN0M0 breast cancer patients.Scientific reports · 2025Article
- Trastuzumab and pertuzumab plus carboplatin-based neoadjuvant therapy for HER2-positive breast cancer: a prospective cohort study with integrated genomic and transcriptomic biomarker analysis.Therapeutic advances in medical oncology · 2025Article
- The interplay between the immune response and neoadjuvant therapy in breast cancer.Frontiers in oncology · 2025Review
- Neratinib enhances the efficacy of CDK4/6 inhibitor plus endocrine therapy in HRScientific reports · 2024Article
- The Biological Roles and Clinical Applications of the PI3K/AKT Pathway in Targeted Therapy Resistance in HER2-Positive Breast Cancer: A Comprehensive Review.International journal of molecular sciences · 2024Review
- Updates in Treatment of HER2-positive Metastatic Breast Cancer.Current treatment options in oncology · 2024Review
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundKRISTINE is an open-label, phase III study of trastuzumab emtansine + pertuzumab (T-DM1 + P) versus docetaxel + carboplatin + trastuzumab + pertuzumab (TCH + P) in patients with HER2-positive, stage II-III breast cancer. We investigated the association of biomarkers with clinical outcomes in KRISTINE.
methodsPatients were randomized to receive neoadjuvant T-DM1 + P or TCH + P and assessed for pathologic complete response (pCR; ypT0/is, ypN0). HER2 status (per central assessment), hormone receptor status, PIK3CA mutation status, HER2/HER3 mRNA levels, tumor-infiltrating lymphocyte levels, PD-L1 status, and NanoString data were analyzed. pCR rates by treatment arm were compared across biomarker subgroups. Analyses were descriptive.
resultsBiomarker analyses included data from all 444 patients (T-DM1 + P, n = 223; TCH + P, n = 221) enrolled in KRISTINE. Biomarker distribution was balanced across treatment arms. All subgroups with higher HER2 amplification/expression and immune marker levels showed numerically higher pCR rates in both arms. Mutated versus non-mutated PIK3CA tumors were associated with numerically lower pCR rates in the T-DM1 + P arm but not in the TCH + P arm. In a multivariate analysis, Prediction Analysis of Microarray with the 50-gene classifier (PAM50) HER2-enriched subtype, HER2 gene ratio ≥ 4, and PD-L1-positive status positively influenced the pCR rate. Biomarkers associated with lower pCR rates (e.g., low HER2 levels, positive hormone receptor status, mutated PIK3CA) were more likely to co-occur. Dynamic on-treatment biomarker changes were observed. Differences in the treatment effects for T-DM1 + P versus TCH + P were similar to those observed in the intent-to-treat population for the majority of the biomarker subgroups.
conclusionsAlthough our biomarker analysis did not identify a subgroup of patients that benefited from neoadjuvant T-DM1 + P versus TCH + P, the data revealed that patients with higher HER2 amplification/expression and immune marker levels had improved response irrespective of treatment arm. These analyses confirm the role of HER2 tumor biology and the immune microenvironment in influencing pCR in the neoadjuvant setting and reaffirm the molecular diversity of HER2-positive breast cancer.
trial registrationClinicalTrials.gov NCT02131064. Registered 06 May 2014.
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.