Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
A Phase II Study of Fulvestrant plus Abemaciclib in Hormone Receptor-Positive Advanced or Recurrent Endometrial Cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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.
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Who cites it
12 citing papers in PubMed.
- Efficacy of everolimus and letrozole with or without ribociclib in recurrent endometrial cancer: a phase 2 randomized clinical trial.Nature communications · 2026Trial
- A pilot translational study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low-grade serous carcinoma.Nature communications · 2026Trial
- Letrozole, abemaciclib and metformin in endometrial cancer: a non-randomized phase 2 trial.Nature communications · 2025Trial
- Decoding the 2023 FIGO Staging System in Endometrial Cancer: A Practical, Visually Guided Framework for Molecular Risk-Adapted Care Incorporating the 2025 Risk Group Update.Current oncology reports · 2026Review
- Endocrine Therapy for Endometrial Carcinoma: Current Evidence, Resistance Mechanisms, and Biomarker-Driven Patient Selection.Current oncology (Toronto, Ont.) · 2026Review
- Review
- Long-term control for > 9 years with megestrol acetate-letrozole: metastatic endometrioid carcinoma case report.Frontiers in oncology · 2026Article
- The Impact of JAK1 Pathogenic Variants and MHC-I Expression on Response to Immune Checkpoint Inhibition in Endometrial Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- "Four years of remission with fulvestrant monotherapy in advanced endometrioid adenocarcinoma of the endometrium Harboring anGynecologic oncology reports · 2025Article
- Functional Profiling of p53 and RB Cell Cycle Regulatory Proficiency Suggests Mechanism-Driven Molecular Stratification in Endometrial Carcinoma.Cancer research communications · 2025Article
- Updates and controversies in the management of uterine serous carcinoma and uterine carcinosarcoma.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025Review
- Drug discovery in advanced and recurrent endometrial cancer: Recent advances.Oncology research · 2025Review
Corrections and comments
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Authors and funding
22 authors.
Funding
Abstract
purposeInhibition of the cyclin D-cyclin-dependent kinase (CDK)4/6-INK4-retinoblastoma pathway can overcome acquired or de novo treatment resistance to endocrine monotherapy. Responses to endocrine monotherapy in advanced endometrial cancer are suboptimal, perhaps due to genomic alterations that promote estrogen receptor-independent cyclin D1-CDK4/6 activation. We hypothesized that the addition of abemaciclib, a CDK4/6 kinase inhibitor, to antiestrogen therapy with fulvestrant would be an effective therapeutic strategy in patients with advanced or recurrent endometrial cancer. PATIENTS AND
methodsIn this phase II study, patients with advanced or recurrent endometrial cancer received 150 mg of abemaciclib orally twice daily with 500 mg of fulvestrant intramuscularly monthly with a 2-week loading dose. Eligibility included estrogen receptor or progesterone receptor expression ≥1% by IHC, measurable disease, ≤2 prior lines of chemotherapy, and ≤1 prior lines of hormonal therapy. The primary endpoint was the objective response rate by RECIST v1.1.
resultsTwenty-seven patients initiated therapy, and 25 were evaluable for efficacy. Eleven patients achieved partial response; 10 responses (91%) were in copy number-low/no specific molecular profile tumors, 1 response (9%) was in a microsatellite instability-high tumor, and no responses were observed in copy number-high/TP53abnormal tumors. The objective response rate was 44% (90% confidence interval, 27.0%-62.1%). The median duration of response was 15.6 months. The median progression-free survival was 9.0 months (90% confidence interval, 1.8-20.4). The most common grade ≥3 treatment-related adverse events were neutropenia (26%) and anemia (19%); no new safety signals were identified.
conclusionsThe combination of abemaciclib and fulvestrant has promising activity with durable responses in advanced or recurrent endometrial cancer; a randomized trial is planned. See related commentary by Garg and Oza, p. 2073.
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