Evidence map›Paper›PMID 32758299›Full record

Trial reportBreast cancer research : BCR2020

EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer.

Laura Biganzoli, Saverio Cinieri, Rossana Berardi, Rebecca Pedersini, Amelia McCartney, Alessandro Marco Minisini, Elena Rota Caremoli, Simon Spazzapan, Emanuela Magnolfi, Antonella Brunello and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02783222 (EFFECT), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

NCT02783222 phase2completednot on this map

EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer

TypeinterventionalSponsorFondazione Sandro PitiglianiRan2013 to 2017Enrolled160ConditionsBreast CancerArmsNab-paclitaxel
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Cardio-Oncology and Breast Cancer Therapies.Current treatment options in oncology · 2025
    Review
  5. Review
  6. Review
  7. 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 17 institutions in 2 countries.

Laura Biganzoli"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy. laura.biganzoli@uslcentro.toscana.it.ORCID 0000-0001-7989-8658
Saverio CinieriDepartment of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.
Rossana BerardiDepartment of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.
Rebecca PedersiniBreast Oncology Unit, Hospital Civili di Brescia, Brescia, Italy.
Amelia McCartney"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.
Alessandro Marco MinisiniDepartment of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.
Elena Rota CaremoliCancer Centre, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Simon SpazzapanUnit of Medical Oncology and Cancer Prevention, IRCCS CRO di Aviano, National Cancer Institute, Aviano, Italy.
Emanuela MagnolfiDepartment of Medical Oncology, Hospital Civile SS Trinità di Sora, Frosinone, Italy.
Antonella BrunelloDepartment of Medical Oncology, Veneto Institute of Oncology IOV Padova, Padua, Italy.
Emanuela Risi"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.
Raffaella PalumboDepartment of Medical Oncology, IRCCS ICS Maugeri, Pavia, Italy.
Silvana LeoDepartment of Medical Oncology, Vito Fazzi Hospital, Lecce, Italy.
Marco ColleoniDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Sara DonatiDepartment of Oncology, Versilia Hospital (Camaiore-Lu), Viareggio, Italy.
Sabino De PlacidoDepartment of Endocrinology and Molecular and Clinical Oncology, AOU Federico II, Naples, Italy.
Laura OrlandoDepartment of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.
Mirco PistelliDepartment of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.
Veronica ParolinDepartment of Medical Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
Anna Mislang"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.
Dimitri BecheriGeriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.
Fabio PuglisiDepartment of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.
Giuseppina Sanna"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.
Elena Zafarana"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.
Luca BoniClinical Trials Centre, AOU University Hospital Careggi, Florence, Italy.
Giuseppe MottinoGeriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.
Hospital of Prato · ITAzienda Usl Toscana Centro · ITMarche Polytechnic University · ITOspedale A. Perrino · ITOspedale Santa Maria della Misericordia di Udine · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Ospedaliero-Universitaria Careggi · ITCentro di Riferimento Oncologico · ITFlinders Medical Centre · AUIstituti Clinici Scientifici Maugeri · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Oncologico Veneto · ITOspedale Papa Giovanni XXIII · ITOspedale Versilia · ITOspedale Vito Fazzi · ITSantissima Trinità · ITUniversity of Brescia · IT

Funding

Celgene IIT29673
6 · The paper itself

Abstract

backgroundLimited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population.

methodsEFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m

resultsAfter a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9-8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2-9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2-3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2-3 arm A vs B, 19% and 38%, respectively).

conclusionPre-specified outcomes were similar in both treatment arms. However, 100 mg/m

trial registrationEudraCT, 2012-002707-18 . Registered on June 4, 2012. NIH ClinicalTrials.gov, NCT02783222 . Retrospectively registered on May 26, 2016.

Indexed as

AgedAged, 80 and overAge FactorsAlbuminsAntineoplastic Agents, PhytogenicBreast NeoplasmsDose-Response Relationship, DrugFemaleHumansNeoplasm InvasivenessNeoplasm StagingPaclitaxelPrognosisSurvival Rate130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelBreast cancerFunctional declineMetastaticNab-paclitaxelOlder adultsToxicity

Identifiers

PMID32758299
PMCPMC7405344
OpenAlexW3047415303

What OpenQuestion holds

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LicenceCC BY
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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.