Evidence map›Paper›PMID 24439313›Full record

Trial reportThe Lancet. Oncology2014

Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial.

Stefan Aebi, Shari Gelber, Stewart J Anderson, István Láng, André Robidoux, Miguel Martín, Johan W R Nortier, Alexander H G Paterson, Mothaffar F Rimawi, José Manuel Baena Cañada and 11 more

3 registry-linked trialsAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 80 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 7 pooled it
–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.

NCT00074152 phase3completednot on this map

A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2002 to 2016Enrolled162ConditionsBreast CancerArmschemotherapy, radiation therapy
NCT02386371 nacompletednot on this map

Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2014 to 2023Enrolled66ConditionsBreast CarcinomaArmstumorectomy, Intra Operative Radiotherapy
NCT03820830 phase3active not recruitingnot on this mapstarted 2019, after this paper: background citation

A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2019 to 2029Enrolled405ConditionsBreast Cancer RecurrentArmsPalbociclib 125mg, Standard endocrine therapy
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. DEGRO practical guidelines for radiotherapy of breast cancer VI: therapy of locoregional breast cancer recurrences.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Guideline
  7. Pooled it
  8. Identifying Locally Recurrent Versus Second Primary Breast Cancer: Genomic Versus Clinical Criteria from Carolina Breast Cancer Study Phase III.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026
    Trial
  9. Detection of Circulating Tumor DNA Using a Tissue-Free Epigenomic Assay Is a Highly Prognostic Biomarker in Early-Stage Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  10. Trial
  11. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Trial
  12. Trial
  13. Observational
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Stefan AebiLuzerner Kantonsspital, Lucerne, Switzerland; University of Berne, Berne, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland. Electronic address: stefan.aebi@onkologie.ch.
Shari GelberInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Frontier Science and Technology Research Foundation, Boston, MA, USA.
Stewart J AndersonNational Surgical Adjuvant Breast and Bowel Project Biostatistical Center, Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
István LángNational Institute of Oncology, Budapest, Hungary.
André RobidouxCentre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Miguel MartínInstituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, Madrid, Spain.
Johan W R NortierLeids Universitair Medisch Centrum, Leiden, Netherlands.
Alexander H G PatersonTom Baker Cancer Centre, Calgary, AB, Canada.
Mothaffar F RimawiBaylor College of Medicine, Houston, TX, USA.
José Manuel Baena CañadaHospital Puerta Del Mar, Cádiz, Spain.
Beat ThürlimannSwiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland; Breast Center, Kantonsspital, St Gallen, Switzerland.
Elizabeth MurrayGroote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
Eleftherios P MamounasMD Anderson Cancer Center, Orlando, FL, USA.
Charles E GeyerVirginia Commonwealth University Massey Cancer Center, Richmond, VA, USA.
Karen N PriceInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Frontier Science and Technology Research Foundation, Boston, MA, USA.
Alan S CoatesInternational Breast Cancer Study Group, Bern, Switzerland; University of Sydney, Sydney, Australia.
Richard D GelberInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Frontier Science and Technology Research Foundation, Boston, MA, USA.
Priya RastogiUniversity of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA, USA.
Norman WolmarkAllegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA, USA.
Irene L WapnirStanford University School of Medicine, Stanford, CA, USA.
CALOR investigators

Funding

PRIMARY CANCER THERAPY GROUP--NSABP (HEADQUARTERS)U10CA012027 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2012
$117.2M
NSABP Foreign AccrualsU10CA037377 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2014
$116.5M
IBCSG STATISTICAL CENTER--A BREAST CANCER STUDY RESOURCEU24CA075362 · NCI · DANA-FARBER CANCER INSTITUTE · PI REGAN, MEREDITH M · 1997 to 2015
$7.5M
NCI NIH HHS U10 CA012027NCI NIH HHS U10 CA037377NCI NIH HHS U10-CA-37377NCI NIH HHS U24 CA075362PHS HHS -12027PHS HHS -69651PHS HHS -69974PHS HHS -75362
6 · The paper itself

Abstract

backgroundPatients with isolated locoregional recurrences (ILRR) of breast cancer have a high risk of distant metastasis and death from breast cancer. We aimed to establish whether adjuvant chemotherapy improves the outcome of such patients.

methodsThe CALOR trial was a pragmatic, open-label, randomised trial that accrued patients with histologically proven and completely excised ILRR after unilateral breast cancer who had undergone a mastectomy or lumpectomy with clear surgical margins. Eligible patients were enrolled from hospitals worldwide and were centrally randomised (1:1) to chemotherapy (type selected by the investigator; multidrug for at least four courses recommended) or no chemotherapy, using permuted blocks, and stratified by previous chemotherapy, oestrogen-receptor and progesterone-receptor status, and location of ILRR. Patients with oestrogen-receptor-positive ILRR received adjuvant endocrine therapy, radiation therapy was mandated for patients with microscopically involved surgical margins, and anti-HER2 therapy was optional. The primary endpoint was disease-free survival. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00074152.

findingsFrom Aug 22, 2003, to Jan 31, 2010, 85 patients were randomly assigned to receive chemotherapy and 77 were assigned to no chemotherapy. At a median follow-up of 4·9 years (IQR 3·6-6 ·0), 24 (28%) patients had disease-free survival events in the chemotherapy group compared with 34 (44%) in the no chemotherapy group. 5-year disease-free survival was 69% (95% CI 56-79) with chemotherapy versus 57% (44-67) without chemotherapy (hazard ratio 0·59 [95% CI 0·35-0·99]; p=0·046). Adjuvant chemotherapy was significantly more effective for women with oestrogen-receptor-negative ILRR (pinteraction=0·046), but analyses of disease-free survival according to the oestrogen-receptor status of the primary tumour were not statistically significant (pinteraction=0·43). Of the 81 patients who received chemotherapy, 12 (15%) had serious adverse events. The most common adverse events were neutropenia, febrile neutropenia, and intestinal infection.

interpretationAdjuvant chemotherapy should be recommended for patients with completely resected ILRR of breast cancer, especially if the recurrence is oestrogen-receptor negative.

fundingUS Department of Health and Human Services, Swiss Group for Clinical Cancer Research (SAKK), Frontier Science and Technology Research Foundation, Australian and New Zealand Breast Cancer Trials Group, Swedish Cancer Society, Oncosuisse, Cancer Association of South Africa, Foundation for Clinical Research of Eastern Switzerland (OSKK), Grupo Español de Investigación en Cáncer de Mama (GEICAM), and the Dutch Breast Cancer Trialists' Group (BOOG).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAustraliaBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDisease ProgressionEuropeFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMastectomyMastectomy, SegmentalNeoplasm Recurrence, LocalNorth AmericaBiomarkers, Tumor

Identifiers

PMID24439313
PMCPMC3982874

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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.