Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024
Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 18 citations in OpenAlex.
- Immune and Growth Factor Signaling Pathways Are Associated with Pathologic Complete Response to an Anti-Type I Insulin-like Growth Factor Receptor Regimen in Patients with Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Pathologic complete response (pCR) rates for patients with HR+/HER2- high-risk, early-stage breast cancer (EBC) by clinical and molecular features in the phase II I-SPY2 clinical trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Trial
- Image Quality Assessment of Diffusion-Weighted Imaging (DWI) and Its Impact on Apparent Diffusion Coefficient (ADC) as a Quantitative Imaging Biomarker for Predicting Response to Neoadjuvant Chemotherapy in High-Risk Early Breast Cancer.Tomography (Ann Arbor, Mich.) · 2026Article
- Protocol and statistical designs in classic clinical research-toripalimab series trial analysis.Cancer biology & medicine · 2026Article
- Article
- Real-time functional proteomics enhances therapeutic targeting in precision oncology molecular tumor boards.NPJ precision oncology · 2025Article
- Convergent inducers and effectors of T cell paralysis in the tumour microenvironment.Nature reviews. Cancer · 2025Review
- Laser capture microdissection.Nature reviews. Methods primers · 2025Article
- Celebrating the 1945 JNCI pioneering contribution to antiangiogenic therapy for cancer.Journal of the National Cancer Institute · 2024Article
- Discerning the impact of ctDNA detection on patient decision-making in early-stage breast cancer.NPJ breast cancer · 2024Article
- Milestones in tumor vascularization and its therapeutic targeting.Nature cancer · 2024Review
- Cyclophosphamide Pharmacogenomic Variation in Cancer Treatment and Its Effect on Bioactivation and Pharmacokinetics.Advances in pharmacological and pharmaceutical sciences · 2024Review
- Applications of Biomolecular Nanostructures for Anti-Angiogenic Theranostics.International journal of nanomedicine · 2024Review
Corrections and comments
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Authors and funding
49 authors at 20 institutions in 2 countries.
Funding
Abstract
purposeThe neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast cancer trial. PATIENTS AND
methodsI-SPY2, a phase II neoadjuvant trial, adaptively randomizes patients with high-risk, early-stage breast cancer to one of several experimental therapies or control based on receptor subtypes as defined by hormone receptor (HR) and HER2 status and MammaPrint risk (MP1, MP2). The primary endpoint is pathologic complete response (pCR). A therapy "graduates" if/when it achieves 85% Bayesian probability of success in a phase III trial within a given subtype. Patients received weekly paclitaxel (plus trastuzumab if HER2-positive) without (control) or with weekly intravenous trebananib, followed by doxorubicin/cyclophosphamide and surgery. Pathway-specific biomarkers were assessed for response prediction.
resultsThere were 134 participants randomized to trebananib and 133 to control. Although trebananib did not graduate in any signature [phase III probabilities: Hazard ratio (HR)-negative (78%), HR-negative/HER2-positive (74%), HR-negative/HER2-negative (77%), and MP2 (79%)], it demonstrated high probability of superior pCR rates over control (92%-99%) among these subtypes. Trebananib improved 3-year event-free survival (HR 0.67), with no significant increase in adverse events. Activation levels of the Tie2 receptor and downstream signaling partners predicted trebananib response in HER2-positive disease; high expression of a CD8 T-cell gene signature predicted response in HR-negative/HER2-negative disease.
conclusionsThe angiopoietin (Ang)/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.
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