Evidence map›Paper›PMID 22763464›Full record

Trial reportBreast cancer research and treatment2012

A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer.

Martin Schuler, Ahmad Awada, Philipp Harter, Jean Luc Canon, Kurt Possinger, Marcus Schmidt, Jacques De Grève, Patrick Neven, Luc Dirix, Walter Jonat and 10 more

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

Trial report in Breast cancer research and treatment, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 6% 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

46 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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
  4. Article
  5. Article
  6. [Breast cancer research : BCR · 2026
    Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Edaravone: A Novel Possible Drug for Cancer Treatment?International journal of molecular sciences · 2024
    Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. 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

20 authors at 14 institutions in 2 countries.

Martin SchulerDepartment of Medical Oncology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Ahmad Awada
Philipp Harter
Jean Luc Canon
Kurt Possinger
Marcus Schmidt
Jacques De Grève
Patrick Neven
Luc Dirix
Walter Jonat
Matthias W Beckmann
Jochen Schütte
Peter A Fasching
Nina Gottschalk
Tatiana Besse-Hammer
Frank Fleischer
Sven Wind
Martina Uttenreuther-Fischer
Martine Piccart
Nadia Harbeck
Boehringer Ingelheim (Germany) · DEInstitut Jules Bordet · BECharité - Universitätsmedizin Berlin · DEComprehensive Cancer Center Erlangen · DEGrand Charleroi Hospital · BEGZA Ziekenhuizen Campus Sint-Augustinus · BEHelios Dr. Horst Schmidt Kliniken Wiesbaden · DEKiel University · DEKU Leuven · BELudwig-Maximilians-Universität München · DEMarien Hospital Düsseldorf · DETechnical University of Munich · DEUniversitätsklinikum Erlangen · DEUniversity of Duisburg-Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits signaling from all relevant ErbB-family dimers. Afatinib has demonstrated preclinical activity in human epidermal growth factor receptor HER2 (ErbB2)-positive and triple-negative xenograft models of breast cancer, and clinical activity in phase I studies. This was a multicenter phase II study enrolling patients with HER2-negative metastatic breast cancer progressing following no more than three lines of chemotherapy. No prior epidermal growth factor receptor-targeted therapy was allowed. Patients received 50-mg afatinib once daily until disease progression. Tumor assessment was performed at every other 28-day treatment course. The primary endpoint was clinical benefit (CB) for ≥4 treatment courses in triple-negative (Cohort A) metastatic breast cancer (TNBC) and objective responses measured by Response Evaluation Criteria in Solid Tumors in patients with HER2-negative, estrogen receptor-positive, and/or progesterone receptor-positive breast cancer (Cohort B). Fifty patients received treatment, including 29 patients in Cohort A and 21 patients in Cohort B. No objective responses were observed in either cohort. Median progression-free survival was 7.4 and 7.7 weeks in Cohorts A and B, respectively. Three patients with TNBC had stable disease for ≥4 treatment courses, one of them for 12 courses (median 26.3 weeks; range 18.9-47.9 weeks). The most frequently observed afatinib-associated adverse events (AEs) were gastrointestinal and skin-related side effects, which were manageable by symptomatic treatment and dose reductions. Afatinib pharmacokinetics were comparable to those observed in previously reported phase I trials. In conclusion, afatinib had limited activity in HER2-negative breast cancer. AEs were generally manageable and mainly affected the skin and the gastrointestinal tract.

Indexed as

AdultAfatinibAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorBreast NeoplasmsCohort StudiesErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsQuinazolinesSurvival AnalysisAfatinibAntineoplastic AgentsBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsQuinazolines

Identifiers

PMID22763464
PMCPMC3409367
OpenAlexW2005448278

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.