Evidence map›Paper›PMID 38112922›Full record

Trial reportBreast cancer research and treatment2024

Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY.

Judith Balmaña, Peter A Fasching, Fergus J Couch, Suzette Delaloge, Intidhar Labidi-Galy, Joyce O'Shaughnessy, Yeon Hee Park, Andrea F Eisen, Benoit You, Hughes Bourgeois and 16 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03286842 (A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03286842 phase3completednot on this map

A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.

TypeinterventionalSponsorAstraZenecaRan2018 to 2021Enrolled256ConditionsHER2-ve Metastatic Breast Cancer, Germline BRCA1/2 Mutations, Somatic BRCA1/2 MutationsArmsOlaparib
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
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  16. Review
  17. Breast Cancer and GeneticGeburtshilfe und Frauenheilkunde · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 11 countries.

Judith BalmañaMedical Oncology Department, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.ORCID http://orcid.org/0000-0002-0762-6415
Peter A FaschingDepartment of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.ORCID http://orcid.org/0000-0003-4885-8471
Fergus J CouchDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-9417-9985
Suzette DelalogeBreast Cancer Unit, Department of Cancer Medicine, Gustave Roussy, Villejuif, France.ORCID https://orcid.org/0000-0003-2106-9165
Intidhar Labidi-GalyDepartment of Oncology, Geneva University Hospital, Department of Medicine, Division of Oncology, Faculty of Medicine, University of Geneva, Geneva, Switzerland.ORCID http://orcid.org/0000-0002-0824-3475
Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology and US Oncology, Dallas, TX, USA.
Yeon Hee ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Andrea F EisenDivision of Medical Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.ORCID http://orcid.org/0000-0001-8037-9556
Benoit YouDepartment of Medical Oncology, Hospices Civils of Lyon Cancer Institute, Centre for Therapeutic Investigation in Oncology and Haematology of Lyon, Lyon Sud Hospital Centre, Lyon, France.ORCID http://orcid.org/0000-0002-3177-8857
Hughes BourgeoisMedical Oncology Department, Victor Hugo Clinic-Jean Bernard Center, Le Mans, France.
Anthony GonçalvesDepartment of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.ORCID http://orcid.org/0000-0001-7570-7439
Zoe KempBreast Cancer Unit, The Royal Marsden NHS Foundation Trust, London, UK.
Angela SwampillaiDepartment of Clinical Oncology, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK.ORCID http://orcid.org/0000-0003-1984-3633
Tomasz JankowskiDepartment of Pneumology, Oncology and Allergology, Medical University of Lublin, Lublin, Poland.ORCID http://orcid.org/0000-0002-0049-7673
Joo Hyuk SohnDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-2303-2764
Elena PoddubskayaSurgical Department N2, Clinical Center VitaMed, Moscow, Russia.ORCID http://orcid.org/0000-0001-6476-6337
Guzel MukhametshinaMinistry of Health of the Republic of Tatarstan, Kazan, Russia.
Sercan AksoyMedical Oncology Department, Hacettepe University Cancer Institute, Ankara, Turkey.ORCID http://orcid.org/0000-0003-4984-1049
Constanta V TimchevaMedical Oncology Department, MHAT Nadezhda, Sofia, Bulgaria.ORCID http://orcid.org/0000-0002-4245-7864
Tjoung-Won Park-SimonFrauenklinik, Hannover Medical School, Hannover, Germany.
Antonio Antón-TorresDepartment of Medical Oncology, Miguel Servet University Hospital and Aragon Health Research Institute, Zaragoza, Spain.ORCID http://orcid.org/0000-0002-9159-4988
Ellie JohnStatistics, AstraZeneca, Cambridge, UK.
Katherine BariaUS Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.
Isabel GibsonGlobal Medical Affairs, AstraZeneca, Cambridge, UK.
Karen A GelmonDepartment of Medical Oncology, BC Cancer, University of British Columbia, Vancouver, Canada. kgelmon@bccancer.bc.ca.ORCID https://orcid.org/0000-0003-4111-2757
LUCY investigators
Medical University of Lublin · PLMedizinische Hochschule Hannover · DEAix-Marseille Université · FRCentre Jean Bernard · FRGuy's Hospital · GBHacettepe University Hospital · TRInstituto de Investigación Sanitaria Aragón · ESRepublican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan · RURoyal Marsden NHS Foundation Trust · GBSamsung Medical Center · KRSunnybrook Health Science Centre · CAUniversitätsklinikum Erlangen · DEYonsei University · KRAstraZeneca (United Kingdom) · GBBC Cancer Agency · CAUniversité Claude Bernard Lyon 1 · FRVall d'Hebron Hospital Universitari · ESArcagy Gineco · FRAstraZeneca (United States) · USInstitut Gustave Roussy · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe interim analysis of the phase IIIb LUCY trial demonstrated the clinical effectiveness of olaparib in patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC), with median progression-free survival (PFS) of 8.11 months, which was similar to that in the olaparib arm of the phase III OlympiAD trial (7.03 months). This prespecified analysis provides final overall survival (OS) and safety data.

methodsThe open-label, single-arm LUCY trial of olaparib (300 mg, twice daily) enrolled adults with gBRCAm or somatic BRCA-mutated (sBRCAm), HER2-negative mBC. Patients had previously received a taxane or anthracycline for neoadjuvant/adjuvant or metastatic disease and up to two lines of chemotherapy for mBC.

resultsOf 563 patients screened, 256 (gBRCAm, n = 253; sBRCAm, n = 3) were enrolled. In the gBRCAm cohort, median investigator-assessed PFS (primary endpoint) was 8.18 months and median OS was 24.94 months. Olaparib was clinically effective in all prespecified subgroups: hormone receptor status, previous chemotherapy for mBC, previous platinum-based chemotherapy (including by line of therapy), and previous cyclin-dependent kinase 4/6 inhibitor use. The most frequent treatment-emergent adverse events (TEAEs) were nausea (55.3%) and anemia (39.2%). Few patients (6.3%) discontinued olaparib owing to a TEAE. No deaths associated with AEs occurred during the study treatment or 30-day follow-up.

conclusionThe LUCY patient population reflects a real-world population in line with the licensed indication of olaparib in mBC. These findings support the clinical effectiveness and safety of olaparib in patients with gBRCAm, HER2-negative mBC. CLINICAL

trial registrationClinical trials registration number: NCT03286842.

Indexed as

Breast NeoplasmsPiperazinesAdultAntineoplastic Combined Chemotherapy ProtocolsFemaleGerm-Line MutationHumansPhthalazinesTreatment OutcomeolaparibPhthalazinesPiperazinesBreast cancerBreast cancer 1 gene productBreast cancer 2 gene productKaplan–Meier survival curvesOlaparibOverall survivalProgression-free survival

Identifiers

PMID38112922
PMCPMC10948524
OpenAlexW4389978835

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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.