Evidence map›Paper›PMID 39520738›Full record

Trial reportBreast (Edinburgh, Scotland)2024

Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study.

Alfonso Cortés, Elena López-Miranda, Adela Fernández-Ortega, Vicente Carañana, Sonia Servitja, Ander Urruticoechea, Laura Lema-Roso, Antonia Márquez, Alexandros Lazaris, Daniel Alcalá-López and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03367689 (A Two-stage Simon Design Phase II Study for NOn-BRCA Metastatic BReast Cancer), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03367689 phase2terminatednot on this map

A Two-stage Simon Design Phase II Study for NOn-BRCA Metastatic BReast Cancer (MBC) Patients With Homologous Recombination Deficiency Treated With OLAparib Single Agent

TypeinterventionalSponsorMedSIRRan2018 to 2021Enrolled7ConditionsBreast CancerArmsOlaparib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
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

17 authors.

Alfonso CortésHospital Universitario Ramón y Cajal, Madrid, Spain.
Elena López-MirandaHospital Universitario Ramón y Cajal, Madrid, Spain; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Adela Fernández-OrtegaInstitut Català d' Oncologia L'Hospitalet (ICO) L'Hospitalet, Barcelona, Spain.
Vicente CarañanaDepartment of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.
Sonia ServitjaHospital del Mar, Barcelona, Spain.
Ander UrruticoecheaGipuzkoa Cancer Unit- Osakidetza/Biodonostia, San Sebastián, Spain.
Laura Lema-RosoHospital Universitario 12 de Octubre, Madrid, Spain.
Antonia MárquezUGCI Oncología Médica, Hospital Universitario Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
Alexandros LazarisMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Daniel Alcalá-LópezMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Leonardo MinaMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Petra GenerMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Jose Rodríguez-MoratóMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA.
Gabriele AntonarelliDepartment of Oncology and Haemato-Oncology (DIPO), University of Milan, Milan, Italy; Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, Italy.
Antonio Llombart-CussacMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain. Electronic address: antoniollombart@medsir.org.
José Pérez-GarcíaMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.
Javier CortésMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut).

methodsNOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.

resultsSix of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2).

conclusionsThe observed results could prompt further investigation. TRIAL: ClinicalTrials.gov identifier NCT03367689.

Indexed as

Germ-Line MutationPhthalazinesPiperazinesTriple Negative Breast NeoplasmsAdultAgedAntineoplastic AgentsBRCA1 ProteinBRCA2 ProteinFemaleHomologous RecombinationHumansMiddle AgedPoly(ADP-ribose) Polymerase InhibitorsTreatment OutcomeAntineoplastic AgentsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsGermline BRCA1/2 mutationsHomologous recombination deficiencyOlaparibPARP inhibitorsTriple-negative breast cancer

Identifiers

PMID39520738
PMCPMC11585816

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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.