Evidence map›Paper›PMID 37028000›Full record

Trial reportESMO open2023

A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA).

L Cortesi, M Venturelli, G Cortesi, F Caggia, A Toss, E Barbieri, U De Giorgi, V Guarneri, A Musolino, E De Matteis and 3 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

13 authors at 7 institutions in 2 countries.

L CortesiDepartment of Oncology and Haematology, University Hospital Modena, Modena. Electronic address: hbc@unimore.it.
M VenturelliDepartment of Oncology and Haematology, University Hospital Modena, Modena.
G CortesiDepartment of Oncology and Haematology, University Hospital Modena, Modena.
F CaggiaDepartment of Oncology and Haematology, University Hospital Modena, Modena.
A TossDepartment of Oncology and Haematology, University Hospital Modena, Modena.
E BarbieriDepartment of Oncology and Haematology, University Hospital Modena, Modena.
U De GiorgiDepartment of Medical Oncology, "Dino Amadori Scientific Institute of Romagna for the Study of Cancer", Meldola.
V GuarneriDepartment of Surgery, Oncology and Gastroenterology, University of Padua, Padova; Division of Oncology, Istituto Oncologico Veneto IRCCS, Padova.
A MusolinoDepartment of Medicine and Surgery, University of Parma, Parma; Medical Oncology, Breast Unit and Cancer Genetics Service, University Hospital of Parma, Parma.
E De MatteisOncology Unit, Hospital "Vito Fazzi", Lecce.
A ZambelliPapa Giovanni XXIII Cancer Center Hospital, Bergamo.
G BisagniOncology Department, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
M DominiciDepartment of Oncology and Haematology, University Hospital Modena, Modena.
Azienda Ospedaliero-Universitaria di Modena · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITOspedale Papa Giovanni XXIII · ITOspedale Vito Fazzi · ITUniversity of Padua · ITUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBRCA1/2-related metastatic breast cancers (mBC) are sensitive to DNA-damage agents and show high tumor-infiltrated lymphocytes. We hypothesized that the association between pembrolizumab and carboplatin could be active in BRCA-related mBC. PATIENTS AND

methodsIn this phase II Simon's design multicenter single-arm study, BRCA1/2-related mBC patients received carboplatin at area under the curve 6 every 3 weeks for six courses associated with 200 mg pembrolizumab every 3 weeks until disease progression or unacceptable toxicity. The primary aim at first stage was overall response rate (ORR) ≥70%. Disease control rate (DCR), time to progression (TTP), duration of response (DOR), and overall survival (OS) were the secondary aims.

resultsAmong 22 patients enrolled at the first stage, 5 BRCA1 and 17 BRCA2, 16 (76%) were luminal tumors and 6 (24%) triple-negative BC (TNBC). In 21 patients, ORR and DCR were 43% and 76% (47% and 87% in luminal, 33% and 50% in TNBC), respectively. TTP was 7.1 months, DOR was 6.3 months, and median OS was not reached. Grade ≥3 adverse events (AEs) or serious AEs occurred in 5/22 patients (22.7%). Since the primary aim was not met, the study was terminated at the first stage.

conclusionsAlthough the primary aim was not reached, data on efficacy and safety of pembrolizumab plus carboplatin in first-line visceral disease BRCA-related luminal mBC were provided and they need to be further investigated.

Indexed as

BRCA1 ProteinTriple Negative Breast NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBRCA2 ProteinCarboplatinHumansAntibodies, Monoclonal, HumanizedBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCarboplatinpembrolizumabBRCA1BRCA2carboplatinpembrolizumabphase II

Identifiers

PMID37028000
PMCPMC10163155
OpenAlexW4362639851

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.