Evidence map›Paper›PMID 24129974›Full record

Trial reportBreast cancer research and treatment2013

Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA).

David Miles, José Baselga, Dino Amadori, Patrapim Sunpaweravong, Vladimir Semiglazov, Adam Knott, Emma Clark, Graham Ross, Sandra M Swain

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT00567190 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

TypeinterventionalSponsorGenentech, Inc.Ran2008 to 2018Enrolled808ConditionsMetastatic Breast CancerArmsPertuzumab, Placebo, Trastuzumab, Docetaxel
NCT03644186 phase2completednot on this mapstarted 2019, after this paper: background citation

Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2019 to 2023Enrolled147ConditionsBreast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast CancerArmsPaclitaxel, Trastuzumab, Pertuzumab, Palbociclib, Letrozole
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.

  1. Pooled it
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  3. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
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  6. Prospective Observational Study on Perioperative Dysgeusia and Trace Metal Elements in Patients Undergoing Pancreatoduodenectomy.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2025
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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

9 authors at 8 institutions in 6 countries.

David MilesMount Vernon Cancer Centre, Rickmansworth Road, Northwood, Middlesex, HA6 2RN, UK, david.miles@doctors.org.uk.
José Baselga
Dino Amadori
Patrapim Sunpaweravong
Vladimir Semiglazov
Adam Knott
Emma Clark
Graham Ross
Sandra M Swain
Roche (Switzerland) · CHInstitute of Oncology NN Petrov · RUIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITMedStar Washington Hospital Center · USMemorial Sloan Kettering Cancer Center · USMount Vernon Cancer Centre · GBPrince of Songkla University · THRoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although the incidence of cancer increases with age, older patients are under-represented in cancer treatment trials, resulting in limited data availability in this patient population. Here we present results from pre-defined subgroup analyses conducted by age group (<65 vs ≥ 65 years) from a randomized, double-blind, placebo-controlled phase III trial in patients with HER2-positive metastatic breast cancer. Patients who had not received previous chemotherapy or biological therapy for HER2-positive locally recurrent, unresectable or metastatic breast cancer were randomly assigned to treatment with placebo, trastuzumab, and docetaxel or with pertuzumab, trastuzumab, and docetaxel. Primary endpoint was independently assessed progression-free survival. We performed pre-specified subgroup analyses of progression-free survival according to age. The study is registered with ClinicalTrials.gov, NCT00567190. 808 patients were enrolled. Of those, 127 patients were 65 years of age or older (placebo arm: 67, pertuzumab arm: 60). Patients in both age groups experienced progression-free survival benefit with treatment in the pertuzumab arm (<65 years: HR: 0.65; 95 % CI 0.53-0.80; ≥65 years: HR: 0.52; 95 % CI 0.31-0.86). Diarrhoea, fatigue, asthenia, decreased appetite, vomiting, and dysgeusia were reported more frequently in patients 65 years of age or older compared with younger patients. Neutropenia and febrile neutropenia were reported less frequently in the older age group. The efficacy and safety data reported in CLEOPATRA suggest that the combined use of pertuzumab, trastuzumab, and docetaxel should not be limited by patient age.

Indexed as

AdultAgedAged, 80 and overAge FactorsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm MetastasisTaxoidsTrastuzumabTreatment OutcomeAntibodies, Monoclonal, HumanizedDocetaxelErb-b2 Receptor Tyrosine KinasespertuzumabTaxoidsTrastuzumab

Identifiers

PMID24129974
PMCPMC3825296
OpenAlexW1983981014

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.