Evidence map›Paper›PMID 24128322›Full record

Trial reportBMC cancer2013

Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial.

Malgorzata Banys, Erich-Franz Solomayer, Gerhard Gebauer, Wolfgang Janni, Natalia Krawczyk, Hans-Joachim Lueck, Sven Becker, Jens Huober, Bernhard Kraemer, Birgit Wackwitz and 3 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00172068 (Efficacy and Tolerability of Intravenous Zometa®), which is not on this map. Cited by 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT00172068 phase2terminatednot on this map

Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2002Enrolled96ConditionsPrimary Breast CancerArmsZoledronic acid + Calcium/Vitamin D
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 3 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Intervening on dormancy to prevent breast cancer recurrence.Nature reviews. Clinical oncology · 2026
    Article
  7. Review
  8. Review
  9. Review
  10. How much do we know about the metastatic process?Clinical & experimental metastasis · 2024
    Review
  11. Targeting cancer cell dormancy.Nature reviews. Cancer · 2024
    Article
  12. Dormancy in Breast Cancer.Cold Spring Harbor perspectives in medicine · 2023
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

13 authors at 8 institutions in 1 country.

Malgorzata Banys
Erich-Franz Solomayer
Gerhard Gebauer
Wolfgang Janni
Natalia Krawczyk
Hans-Joachim Lueck
Sven Becker
Jens Huober
Bernhard Kraemer
Birgit Wackwitz
Peter Hirnle
Diethelm Wallwiener
Tanja FehmDepartment of Gynecology and Obstetrics, Heinrich-Heine University of Düsseldorf, Moorenstr, 5, 40225, Düsseldorf, Germany. tanja.fehm@t-online.de.
Heinrich Heine University Düsseldorf · DEUniversity of Tübingen · DEMarienkrankenhaus Hamburg · DEMedizinische Hochschule Hannover · DENovartis (Germany) · DESaarland University · DEUniversität Ulm · DEUniversity Hospital Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe presence of disseminated tumor cells (DTC) in bone marrow (BM) of breast cancer patients is associated with reduced clinical outcome. Bisphosphonate treatment was shown to eradicate DTC from BM in several studies. This controlled randomized open-label multi-center study aimed to investigate the influence of zoledronic acid (ZOL) on DTC and survival of breast cancer patients (Clinical Trial Registration Number: NCT00172068).

methodsPatients with primary breast cancer and DTC-positive bone marrow were randomized to treatment with ZOL plus adjuvant systemic therapy (n = 40) or adjuvant systemic therapy alone (n = 46) between 03/2002 and 12/2004. DTC were identified by immunocytochemistry using the pancytokeratin antibody A45B/B3 and by cytomorphology. The change in DTC numbers at 12 months and 24 months versus baseline, as well as patient outcomes were evaluated.

results86 patients could be included into survival analysis (median follow-up: 88 months, range: 8-108 mths). Patients in the control group were more likely to die during follow-up than those in the ZOL-group (11% vs. 2%, p = 0.106). 15% of patients in the control group presented with relapse whereas only 8% of ZOL group patients developed metastatic or recurrent disease during follow-up (p = 0.205). At 24 months, 16% of patients from the control group were still DTC positive, whereas all patients treated with ZOL became DTC negative (p = 0.032). Patients presenting with persistent DTC 12 months after diagnosis had significantly shorter overall survival (p = 0.011).

conclusionsBisphosphonate therapy contributes to eradication of disseminated tumor cells. The positive influence of bisphosphonates on survival in the adjuvant setting may be due to their effects on DTC.

trial registrationClinicalTrials.gov Identifier: NCT00172068 [Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow (MRD-1)].

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBone Density Conservation AgentsBone MarrowBreast NeoplasmsChemoradiotherapy, AdjuvantDiphosphonatesFemaleFollow-Up StudiesHumansImidazolesNeoplasm GradingNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingTime FactorsTumor BurdenBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID24128322
PMCPMC4015285
OpenAlexW2054923667

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.