Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019
A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB).
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses that pooled it.
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
59 citing papers in PubMed, 3 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.Breast cancer research : BCR · 2024Pooled it
- Efficacy and Safety of Phosphatidylinositol 3-kinase Inhibitors for Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Current cancer drug targets · 2024Pooled it
- CDK4/6 inhibitors versus PI3K/AKT/mTOR inhibitors in women with hormone receptor-positive, HER2-negative metastatic breast cancer: An updated systematic review and network meta-analysis of 28 randomized controlled trials.Frontiers in oncology · 2022Pooled it
- Safety and efficacy of low-dose PI3K inhibitor taselisib in adult patients with CLOVES and Klippel-Trenaunay syndrome (KTS): the TOTEM trial, a phase 1/2 multicenter, open-label, single-arm study.Genetics in medicine : official journal of the American College of Medical Genetics · 2021Trial
- Breast Cancer Treatments: Drugs Targeting the PI3K/AKT/mTOR Pathway, TNBC Therapy and Future Directions: A Review.Life (Basel, Switzerland) · 2025Review
- Long-term Outcomes for Neoadjuvant Versus Adjuvant Chemotherapy in ER+/HER2- Locally Advanced Breast Cancer.Annals of surgical oncology · 2025Article
- Linperlisib causing high blood sugar and hyponatremia, leading to facial nerve paralysis and muscle nerve damage: A rare case report.Medicine · 2025Article
- Targeting PI3K Signaling to Overcome Tumor Immunosuppression: Synergistic Strategies to Enhance Cancer Vaccine Efficacy.Vaccines · 2025Review
- Application status and research progress of targeted therapy drugs for hormone receptor-positive breast cancer.Frontiers in medicine · 2025Review
- FBXO32-mediated degradation of PTEN promotes lung adenocarcinoma progression.Cell death & disease · 2024Article
- Discovery of Pyridopyrimidinones that Selectively Inhibit the H1047R PI3Kα Mutant Protein.Journal of medicinal chemistry · 2024Article
- Molecular Targeting of the Phosphoinositide-3-Protein Kinase (PI3K) Pathway across Various Cancers.International journal of molecular sciences · 2024Review
- Endocrine Therapy: From Ovarian Ablation to Individualized Therapy and Signal Inhibition.Breast care (Basel, Switzerland) · 2023Review
- PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer.Molecular cancer · 2023Review
- Beyond Skin Rash: Alpelisib-Induced Anaphylactic Reactions.The oncologist · 2023Article
- Review
- Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer.International journal of molecular sciences · 2023Review
- Phosphoinositide 3-Kinase (PI3K) Inhibitors and Breast Cancer: An Overview of Current Achievements.Cancers · 2023Review
- Neoadjuvant endocrine therapy in ER-positive breast cancer: evolution, indication, and tailored treatment strategy.Therapeutic advances in medical oncology · 2023Review
- Targeting PI3K/AKT/mTOR Pathway in Breast Cancer: From Biology to Clinical Challenges.Biomedicines · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 19 institutions in 8 countries.
Funding
Abstract
purposeAddition of alpelisib to fulvestrant significantly extended progression-free survival in
resultsIn total, 257 patients were assigned to letrozole plus alpelisib (131 patients) or placebo (126 patients). Grade ≥3 adverse events (≥5% of patients) in the alpelisib arm were hyperglycemia (27%), rash (12%), and maculo-papular rash (8%). The primary objective was not met; ORR in the alpelisib versus placebo arm was 43% versus 45% and 63% versus 61% in the
conclusionsIn contrast to initial results in advanced/metastatic disease, addition of alpelisib to 24-week neoadjuvant letrozole treatment did not improve response in patients with HR
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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.