ArticleBreast care (Basel, Switzerland)2021
First Experiences with Alpelisib in Clinical Routine: Case Reports from a German Breast Center.
Article in Breast care (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03706573 (Managed Access Program), which is not on this map. Cited by 5 papers.
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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.
Managed Access Program (MAP) to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer Resistant or Refractory to Available Treatment Options
Who cites it
5 citing papers in PubMed, 5 citations in OpenAlex.
- Oncogenic activation ofGenes & diseases · 2025Review
- A multidisciplinary approach to optimizing care of patients treated with alpelisib.Breast (Edinburgh, Scotland) · 2022Review
- Real world outcomes with alpelisib in metastatic hormone receptor-positive breast cancer patients: A single institution experience.Frontiers in oncology · 2022Article
- Review
- Luminal Metastatic Breast Cancer: Current Concepts and Future Approaches.Breast care (Basel, Switzerland) · 2021Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib is the only approved agent for treating -
methodsIn a managed access program (ClinicalTrials.gov ID: NCT03706573; start: 06/2019), 8 HR+ HER2- ABC patients with a median 4.5 prior therapy lines were treated with alpelisib at the Breast Center of the Ludwig-Maximilian University (LMU) Hospital, Munich, based on the results of a new-generation sequencing (NGS) panel and
resultsMedian therapy duration was 3.42 months for patients who discontinued and 3.95 months for those still on alpelisib (4 pts). Five had hyperglycemia (1 with grade 3) with fasting glucose levels of up to 450 mg/dL that required hospitalization and insulin therapy. Two experienced rash (grades 1 and 3) and 2 reported grade 3 diarrhea. Supportive therapy as well as interruption and/or dose reduction were necessary to control treatment-associated side effects.
conclusionPatient education and a well-trained, interdisciplinary team including diabetologists, from the initiation of alpelisib treatment onwards, are essential to safely treat ABC patients with this new drug and to maintain their quality of life and ensure their survival.
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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.