Evidence map›Paper›PMID 35442755›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Daily Oral Ibandronate With Adjuvant Endocrine Therapy in Postmenopausal Women With Estrogen Receptor-Positive Breast Cancer (BOOG 2006-04): Randomized Phase III TEAM-IIB Trial.

Sonja B Vliek, Iris Noordhoek, Elma Meershoek-Klein Kranenbarg, Annelot G J van Rossum, Vincent O Dezentje, Agnes Jager, J W Esmeralda Hokken, Hein Putter, Annette W G van der Velden, Mathijs P Hendriks and 8 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 5 countries.

Sonja B VliekDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0002-7300-7436
Iris NoordhoekDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0003-1204-0993
Elma Meershoek-Klein KranenbargDepartment of Surgery, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0002-1750-2221
Annelot G J van RossumDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Vincent O DezentjeDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Agnes JagerDutch Breast Cancer Research Group, Amsterdam, the Netherlands.
J W Esmeralda HokkenDepartment of Medical Oncology, Groene Hart Ziekenhuis, Gouda, the Netherlands.
Hein PutterDepartment of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0001-5395-1422
Annette W G van der VeldenDepartment of Internal Medicine, Martini Hospital, Groningen, the Netherlands.
Mathijs P HendriksDepartment of Medical Oncology, Northwest Clinics, Alkmaar, the Netherlands.ORCID 0000-0001-6687-5393
Sandra D BakkerDepartment of Internal Medicine, Zaans Medical Centre, Zaandam, the Netherlands.
Yvonne E A van RietDepartment of Surgical Oncology, Catharina Hospital, Eindhoven, the Netherlands.ORCID 0000-0002-4465-5768
Vivianne C G Tjan-HeijnenDepartment of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.
Johanneke E A PortieljeDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0002-5169-6306
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0003-2671-1903
Johan W R NortierDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.
Cornelis J H van de VeldeDepartment of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
Sabine C LinnDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0001-5541-0347
Leiden University Medical Center · NLThe Netherlands Cancer Institute · NLGroene Hart Ziekenhuis · NLMaastricht University · NLMartini Ziekenhuis · NLNorthwest Hospital · USRadboud University Nijmegen · NLRoche (Switzerland) · CHZaans Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFor postmenopausal patients with breast cancer, previous subgroup analyses have shown a modest benefit from adjuvant bisphosphonate treatment. However, the efficacy of oral nitrogen-containing bisphosphonates such as ibandronate is unclear in this setting. TEAM-IIB investigates adjuvant ibandronate in postmenopausal women with estrogen receptor-positive (ER+) breast cancer.

methodsTEAM-IIB is a randomized, open-label, multicenter phase III study. Postmenopausal women with stage I-III ER+ breast cancer and an indication for adjuvant endocrine therapy (ET) were randomly assigned 1:1 to 5 years of ET with or without oral ibandronate 50 mg once daily for 3 years. Major ineligibility criteria were bilateral breast cancer, active gastroesophageal problems, and health conditions that might interfere with study treatment. Primary end point was disease-free survival (DFS), analyzed in the intention-to-treat population.

resultsBetween February 1, 2007, and May 27, 2014, 1,116 patients were enrolled, 565 to ET with ibandronate (ibandronate arm) and 551 to ET alone (control arm). Median follow-up was 8.5 years. DFS was not significantly different between the ibandronate and control arms (HR, 0.97; 95% CI, 0.76 to 1.24; log-rank

conclusionIn postmenopausal women with ER+ breast cancer, adjuvant ibandronate 50 mg once daily does not improve DFS and should not be recommended as part of standard treatment regimens.

Indexed as

Breast NeoplasmsChemotherapy, AdjuvantDiphosphonatesDisease-Free SurvivalFemaleHumansIbandronic AcidPostmenopauseReceptors, EstrogenDiphosphonatesIbandronic AcidReceptors, Estrogen

Identifiers

PMID35442755
OpenAlexW4224232679

What OpenQuestion holds

Textmetadata
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.