ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
Patient-Reported Outcomes in Patients With
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02437318 (A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment), which is not on this map. Cited by 22 papers, 5 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.
A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Who cites it
22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Application of PI3K inhibitors in breast cancer treatment: a clinical trial landscape analysis based on clinical trial databases and registries.Frontiers in oncology · 2026Pooled it
- Next-generation sequencing for guiding matched targeted therapies in people with relapsed or metastatic cancer.The Cochrane database of systematic reviews · 2025Pooled it
- Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer.ESMO open · 2023Guideline
- Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Pooled it
- Quality of life of therapies for hormone receptor positive advanced/metastatic breast cancer: Regulatory aspects and clinical impact in Europe.Breast (Edinburgh, Scotland) · 2021Pooled it
- Article
- Continuing Cyclin-Dependent Kinase 4/6 Inhibitors Beyond Progression in Advanced Breast Cancer: A Meta-Analysis.Cancers · 2025Review
- Optimizing second-line endocrine-based treatment in HR positive HER2 negative metastatic breast cancer: a comprehensive expert statement from the Gulf Cooperation Council Region.Frontiers in oncology · 2025Review
- Therapeutic evolution in HR+/HER2- breast cancer: from targeted therapy to endocrine therapy.Frontiers in pharmacology · 2024Review
- Advances in Trop-2 targeted antibody-drug conjugates for breast cancer: mechanisms, clinical applications, and future directions.Frontiers in immunology · 2024Review
- Genetic Testing Enhances the Precision Diagnosis and Treatment of Breast Cancer.International journal of molecular sciences · 2023Review
- Clinicopathological features and prognosis of breast cancer combined with symptomatic bone marrow metastases: A 10-year, single-center, real-world study of 67 cases.Cancer medicine · 2023Article
- How I treat endocrine-dependent metastatic breast cancer.ESMO open · 2023Review
- Review
- Genetic Heterogeneity and Tissue-specific Patterns of Tumors with Multiple PIK3CA Mutations.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Article
- Biology and Targetability of the Extended Spectrum of PIK3CA Mutations Detected in Breast Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Article
- Phosphoinositide 3-Kinase (PI3K) Inhibitors and Breast Cancer: An Overview of Current Achievements.Cancers · 2023Review
- At a crossroads: how to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy.Nature reviews. Clinical oncology · 2022Review
- Alpelisib: A Well-Tolerated Treatment Option for Patients with HR-Positive, HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.Global medical genetics · 2022Article
- Real world outcomes with alpelisib in metastatic hormone receptor-positive breast cancer patients: A single institution experience.Frontiers in oncology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 17 institutions in 8 countries.
Funding
Abstract
purposeIn the phase III SOLAR-1 trial (NCT02437318), the PI3Kα-selective inhibitor and degrader alpelisib significantly improved median progression-free survival when added to fulvestrant in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha ( MATERIALS AND
methodsIn the
resultsGlobal Health Status/QoL and functional status were maintained from baseline (mean changes < 10 points) in the alpelisib (overall change from baseline [95% CI], -3.50 [-8.02 to 1.02]) and placebo arms (overall change from baseline [95% CI], 0.27 [-4.48 to 5.02]). Overall treatment effect in Global Health Status/QoL was not significantly different between arms (-3.77; 95% CI, -8.35 to 0.80;
conclusionIn SOLAR-1, there was no statistical difference in deterioration of Global Health Status/QoL between arms, whereas symptom subscales favored placebo for diarrhea, appetite loss, nausea or vomiting, and fatigue, known side effects of alpelisib. Treatment decisions must consider efficacy and tolerability; taken with clinical efficacy, these results support the benefit-risk profile of alpelisib in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative
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.