Evidence map›Paper›PMID 26835225›Full record

ArticleSpringerPlus2016

A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole.

Katharina Gunzer, Florence Joly, Jean-Marc Ferrero, Joseph Gligorov, Helene de Mont-Serrat, Martina Uttenreuther-Fischer, Katy Pelling, Sven Wind, Guilhem Bousquet, Jean-Louis Misset

Registry-linked trialAbstract read
In one paragraph

Article in SpringerPlus, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00708214 (A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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.

NCT00708214 phase2completednot on this map

A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer

TypeinterventionalSponsorBoehringer IngelheimRan2007Enrolled28ConditionsBreast NeoplasmsArmsBIBW 2992, Letrozole
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Effects of HER Family-targeting Tyrosine Kinase Inhibitors on Antibody-dependent Cell-mediated Cytotoxicity in HER2-expressing Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  3. Article
  4. Review
  5. Article
  6. Personalized medicine in breast cancer: pharmacogenomics approaches.Pharmacogenomics and personalized medicine · 2019
    Review
  7. Review
  8. Article
  9. 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

10 authors.

Katharina GunzerOncologue-Service de Recherche Clinique, Centre François Baclesse, Avenue Général Harris, 14076 Caen Cedex 05, France.
Florence JolyOncologue-Service de Recherche Clinique, Centre François Baclesse, Avenue Général Harris, 14076 Caen Cedex 05, France ; Centre Hospitalier Universitaire Côte de Nacre, Caen, France.
Jean-Marc FerreroCentre Antoine Lacassagne, Nice, France.
Joseph GligorovAPHP, HUEP-Tenon Hospital, Paris, France ; Institut Universitaire de Cancérologie, UPMC, Paris, France.
Helene de Mont-SerratBoehringer Ingelheim France S.A.S., Reims, France.
Martina Uttenreuther-FischerBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach, Germany.
Katy PellingBoehringer Ingelheim Ltd., Bracknell, UK.
Sven WindBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach, Germany.
Guilhem BousquetHôpital Saint Louis, Paris, France.
Jean-Louis MissetHôpital Saint Louis, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledPhase II, open-label study assessing the efficacy and safety of the ErbB family blocker afatinib combined with letrozole in estrogen receptor-positive metastatic breast cancer (MBC) patients who had progressed on letrozole monotherapy. Adult females (N = 28) received oral afatinib (50 [n = 7], 40 [n = 13] or 30 [n = 8] mg/day) plus letrozole 2.5 mg/day in 28-day cycles until disease progression. Primary endpoint was the progression-free rate at or after 16 weeks of afatinib. At 16 weeks, four patients remained on afatinib without progression; two of these were HER2 negative. Fifteen (54 %) patients had a best response of stable disease according to Response Evaluation Criteria in Solid Tumors. Median progression-free survival was 60, 107 and 79 days with 50, 40 and 30 mg/day afatinib, respectively. Diarrhea, asthenia, rash, mucosal inflammation and nausea were the most frequent adverse events. In this small, exploratory study, afatinib combined with letrozole was able to induce disease stabilization in 54 % of hormone-refractory MBC patients previously progressing on letrozole. CLINICAL

trial registrationNCT00708214.

Indexed as

AfatinibErbB Family BlockerLetrozoleMetastatic breast cancerPharmacokineticsPhase II

Identifiers

PMID26835225
PMCPMC4718910

What OpenQuestion holds

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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.