Trial Results: ECOG-ACRIN Research Round-Up

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Below are summaries of recently published analyses from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN). Click on the shortened citations to access the publications.

Breast Cancer – Overtreatment is a concern in ductal carcinoma in situ (DCIS), as mastectomies and radiation treatments can add side effects without improving outcomes for some patients. The prospective, nonrandomized E4112 trial demonstrated that combined use of two diagnostic tools—preoperative breast MRI and DCIS gene expression testing—helps DCIS patients and their physicians select more personalized local therapy (Lehman CD. JAMA Oncol. 2019). The now-published 5-year follow-up adds important long-term data. Participants who underwent lumpectomy based on their preoperative MRI and opted out of radiation therapy based on a low Oncotype DX DCIS Score® risk score (less than 39) did not experience an increased risk of recurrence. Ipsilateral breast recurrence rates were low and similar across risk groups, at approximately 1% per year. This finding supports the safe omission of radiation in patients with low-risk DCIS. Patients continue to be followed for 10-year results. Radiotherapy With a 12-Gene Expression Assay for Ductal Carcinoma in Situ: A Randomized Clinical TrialKhan SA. JAMA Oncology. October 2025.

Breast Cancer – The New England Journal of Medicine has published the final results of the pivotal PATINA trial. This phase 3 study found that adding palbociclib to anti-HER2 and endocrine therapy, following induction chemotherapy, delayed disease progression in patients with HR+, HER2+ metastatic breast cancer. Adding palbociclib, a well-tolerated oral medication, to standard treatment provided prolonged disease control for a currently incurable condition. Results showed a 15-month improvement in median progression-free survival times with palbociclib compared to the control arm (44.3 months versus 29.1 months, respectively). Metzger O. N Engl J Med. January 2026. Also read the PrECOG press release.

Breast Cancer Screening – Randomized clinical trials (RCTs) have demonstrated that mammography is effective in saving lives; however, these studies require substantial time and financial resources. In this article, breast imaging experts from ECOG-ACRIN outline the advantages and disadvantages of RCTs and explore professional efforts to more rapidly assess and incorporate new technologies “in a reasoned and evidence-based fashion.” Do We Still Need Randomized Controlled Trials to Support Use of New Methods of Breast Cancer Screening? McDonald ES. J Breast Imaging. November 2025.

Cancer Care Delivery Research – New data from the EAQ171CD study add to growing evidence of gender gaps in access to tobacco cessation treatment for people with cancer. The analysis found that women were less likely than men to receive smoking cessation assistance or follow-up from their oncology clinicians through the 5As framework (Ask, Advise, Assess, Assist, and Arrange follow-up). The authors identify an addressable gap in access to tobacco treatment that could lead to better quit outcomes for women with cancer. Exploring Gender Differences in Receipt of the 5As for Smoking Cessation for Recently Diagnosed Cancer Patients (ECOG-ACRIN EAQ171CD). Finkelstein-Fox L. Nicotine Tob Research. October 2025.

Health Equity and Geriatric Oncology – The first comprehensive assessment of participation among older adults in ECOG-ACRIN cancer clinical trials examined the involvement of both patients and clinical sites across 15 studies from 2005 to 2019. Only 26% of participants were aged ≥65, despite comprising half of all cancer patients in the United States. Restrictive eligibility criteria and underrepresentation of older adults was worse in the Black/African American population. Community sites enrolled slightly more older adults than academic centers, but overall rates remained low. This study examines how disease type, eligibility criteria, practice setting, race/ethnicity, and performance status affect enrollment. Unveiling Factors Associated with Older Adult Accrual to Cancer Clinical Trials: Lessons From the ECOG-ACRIN Experience. Pearson LK. J Natl Compr Canc Netw. December 2025.

Leukemia and Experimental Imaging – Results are now published from the first prospective, multicenter molecular imaging study for patients with previously untreated acute myeloid leukemia (AML). FLT PET/CT imaging was feasible in a multicenter setting for patients with AML, but, on its own, did not predict treatment response better than the standard day-14 bone marrow biopsy. Also, the day-14 marrow assessment had limited accuracy, a finding suggesting that combining early molecular imaging with marrow evaluation at an earlier time point may improve response assessment compared with using either method alone. Early Assessment of Treatment Response in AML Using FLT PET/CT: A Trial of the ECOG-ACRIN Cancer Research Group (EAI141). Jeraj R. Leuk Lymphoma. November 2025.

NCI-MATCH – Arm Z1K met its primary endpoint, with ipatasertib showing clinically significant activity in heavily pretreated patients with various tumors harboring AKT1E17K mutations. These findings warrant further investigation in a larger study. Ipatasertib in Patients with Tumors with AKT Mutations: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1K. McCourt CK. Clin Cancer Res. December 2025.

NCI-MATCH – Analysis of circulating tumor DNA (ctDNA) in the blood (liquid biopsy) is increasingly being explored as a noninvasive way to detect genomic alterations in patients with cancer that may be treatable with targeted drugs. In an analysis of plasma samples collected from patients in the NCI-MATCH trial, ctDNA testing identified the same targetable tumor alterations as biopsy tissue sequencing in 81% of patients with paired samples. Researchers noted that, in all cases, tissue testing has been performed centrally. The findings suggest a potential role for liquid biopsies to facilitate patient enrollment in biomarker-driven clinical trials. Concordance between Tumor Tissue and Plasma DNA Genotyping in the NCI-MATCH Trial (EAY131). Gouda MA. Clin Cancer Res. October 2025.

Symptom Science and Patient-Reported Outcomes – Cancer treatment tolerability is essential for reducing suffering and mortality from this disease. A recent special issue of Cancer presents research from the Cancer Treatment Tolerability Consortium, a program of the National Cancer Institute (NCI) through its Division of Cancer Prevention. ECOG-ACRIN is a participant through its EVOLV initiative. The special issue features eight manuscripts on a range of topics: the link between treatment side effect bother and discontinuation, decision regret among older adults on systemic therapy, adverse events measured by the toxicity index, multidimensional aspects of tolerability, the absence of young children’s voices in pediatric tolerability assessments, an NCI report on consortium future directions, efforts to optimize patient-reported outcomes measures, and the FDA regulatory perspective on assessing tolerability of cancer therapies. Special Issue: Analyzing and Reporting the Impact of Cancer Therapies on Tolerability: Findings from the NCI Tolerability Consortium. Cancer: Volume 131, Issue S2. October 2025.

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