Evidence map›Paper›PMID 25547219›Full record

Trial reportBreast cancer research and treatment2015

Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer.

Michael R Clemens, Oleg A Gladkov, Elaina Gartner, Vladimir Vladimirov, John Crown, Joyce Steinberg, Fei Jie, Anne Keating

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

Trial report in Breast cancer research and treatment, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 7% 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

58 citing papers in PubMed, 3 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Ubiquitin System-Driven Proteostasis in DNA Damage Response.International journal of molecular sciences · 2026
    Review
  5. Article
  6. Review
  7. Targeting Survivin: Now I Become Death, the Destroyer of Cells.International journal of molecular sciences · 2025
    Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Combined Inhibition ofInternational journal of molecular sciences · 2023
    Article
  14. TP53RK Drives the Progression of Chronic Kidney Disease by Phosphorylating Birc5.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    Article
  15. Article
  16. Article
  17. Review
  18. Article
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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

8 authors at 6 institutions in 4 countries.

Michael R ClemensInnere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier, Germany, Clemens@mutterhaus.de.
Oleg A Gladkov
Elaina Gartner
Vladimir Vladimirov
John Crown
Joyce Steinberg
Fei Jie
Anne Keating
Astellas Pharma (United States) · USCancer Trials Ireland · IEChelyabinsk Regional Clinical Oncology Center · RUKlinikum Mutterhaus der Borromäerinnen · DEPyatigorsk Oncology Center · RUThe Barbara Ann Karmanos Cancer Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study was to assess the efficacy and tolerability of YM155, a survivin suppressor, in combination with docetaxel, compared with docetaxel alone in patients with HER2-negative metastatic breast cancer. This phase II, multicenter, open-label, 2-arm study randomized patients (≥18 years) with histologically or cytologically confirmed stage IV HER2-negative metastatic breast cancer and ≥1 measurable lesion, to receive docetaxel alone or docetaxel plus YM155. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR), biomarker assessment, and analysis of circulating tumor cells. Patients were women diagnosed with HER2-negative breast cancer; most had received prior drug therapies. The median PFS was 8.4 months with YM155 plus docetaxel (n = 50) and 10.5 months with docetaxel alone (n = 51; HR 1.53; 95 % CI 0.83, 2.83; P = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; P = 0.768), CBR (84.3 vs 82.0 %; P = 0.855), DOR, and TTR were observed with docetaxel alone compared with YM155 plus docetaxel, whereas ORR was similar (25.5 vs 26.0). The most common TEAEs observed with YM155 plus docetaxel compared with docetaxel alone were neutropenia (83.3 vs 84.3 %), alopecia (62.5 vs 52.9 %), fatigue (50 vs 41.2 %), and nausea (37.5 vs 41.2 %). Although YM155 is a novel drug that suppresses survivin, YM155 plus docetaxel exhibited no statistically significant differences in endpoints compared with docetaxel alone. The combination regimen was well tolerated.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDocetaxelDrug-Related Side Effects and Adverse ReactionsErb-b2 Receptor Tyrosine KinasesFemaleHumansImidazolesLymphatic MetastasisMiddle AgedNaphthoquinonesTaxoidsTreatment OutcomeDocetaxelErb-b2 Receptor Tyrosine KinasesImidazolesNaphthoquinonessepantroniumTaxoids

Identifiers

PMID25547219
PMCPMC4298663
OpenAlexW1971162671

What OpenQuestion holds

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LicenceCC BY-NC
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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.