Evidence map›Paper›PMID 26092816›Full record

Trial reportThe Lancet. Oncology2015

Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials.

Jürg Bernhard, Weixiu Luo, Karin Ribi, Marco Colleoni, Harold J Burstein, Carlo Tondini, Graziella Pinotti, Simon Spazzapan, Thomas Ruhstaller, Fabio Puglisi and 11 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2015. 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 90 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 7 pooled it
17.8field-weighted citation impact, top 1% 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.

NCT00066690 phase3completednot on this map

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2003 to 2024Enrolled3,066ConditionsEstrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast CancerArmsExemestane, Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy
NCT00066703 phase3completednot on this map

A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2003 to 2024Enrolled2,672ConditionsBreast CancerArmsexemestane, tamoxifen, triptorelin
NCT03917082 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2019 to 2029Enrolled290ConditionsBreast Cancer Female, Hormone Receptor Positive TumorArmsTamoxifen Citrate
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 7 syntheses or guidelines pooled it, 175 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Trial
  9. Trial
  10. Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Review
  20. Observational

30 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 at 14 institutions in 5 countries.

Jürg BernhardInternational Breast Cancer Study Group Coordinating Center and Bern University Hospital, Inselspital, Bern, Switzerland. Electronic address: juerg.bernhard@ibcsg.org.
Weixiu LuoInternational Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.
Karin RibiInternational Breast Cancer Study Group Coordinating Center, Bern, Switzerland.
Marco ColleoniDivision of Medical Senology, European Institute of Oncology and International Breast Cancer Study Group, Milan, Italy.
Harold J BursteinDana-Farber Cancer Institute and Alliance for Clinical Trials in Oncology, Boston, MA, USA.
Carlo TondiniMedical Oncology, Osp Papa Giovanni XXIII and International Breast Cancer Study Group, Bergamo, Italy.
Graziella PinottiMedical Oncology, Ospedale di Circolo and Fondazione Macchi, and International Breast Cancer Study Group, Varese, Italy.
Simon SpazzapanMedical Oncology, Centro di Riferimento Oncologico, and International Breast Cancer Study Group, Aviano, Italy.
Thomas RuhstallerBreast Center, Kantonsspital St Gallen, Swiss Group for Clinical Cancer Research (SAKK), and International Breast Cancer Study Group, St Gallen, Switzerland.
Fabio PuglisiDepartment of Oncology, University Hospital of Udine, University of Udine and International Breast Cancer Study Group, Udine, Italy.
Lorenzo PavesiOncology Unit, Salvatore Maugeri Foundation, and International Breast Cancer Study Group, Pavia, Italy.
Vani ParmarSurgical Oncology, Breast Services, Tata Memorial Hospital, and International Breast Cancer Study Group, Mumbai, India.
Meredith M ReganInternational Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Olivia PaganiInstitute of Oncology of Southern Switzerland, Swiss Group for Clinical Cancer Research, and International Breast Cancer Study Group, Lugano Viganello, Switzerland.
Gini F FlemingUniversity of Chicago Medical Center and Alliance for Clinical Trials in Oncology, Chicago, IL, USA.
Prudence A FrancisPeter MacCallum Cancer Center, St Vincent's Hospital, University of Melbourne, Melbourne and Australia and New Zealand Breast Cancer Trials Group, Newcastle, NSW, Australia, and International Breast Cancer Study Group.
Karen N PriceInternational Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA.
Alan S CoatesInternational Breast Cancer Study Group and University of Sydney, Sydney, NSW, Australia.
Richard D GelberInternational Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard School of Public Health, Frontier Science and Technology Research Foundation, Boston, MA, USA.
Aron GoldhirschProgram for Breast Health (Senology), European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group, Bern, Switzerland.
Barbara A WalleyTom Baker Cancer Centre and National Cancer Institute of Canada Clinical Trials Group, Calgary, AB, Canada.
International Breast Cancer Study Group · CHBreast Cancer Trials · AUDana-Farber Cancer Institute · USEuropean Institute of Oncology · ITFrontier Science & Technology Research Foundation · USAlliance for Clinical Trials in Oncology · USCentro di Riferimento Oncologico · ITFondazione Salvatore Maugeri · ITKantonsspital St. Gallen · CHOspedale di Circolo e Fondazione Macchi · ITOspedale Papa Giovanni XXIII · ITTata Memorial Hospital · INUniversity of Chicago Medical Center · USUniversity of Udine · IT

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
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
STUDY TO ASSESS RALOXIFENE FOR PREVENTING BREAST CANCERU10CA069974 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2013
$62.4M
PRIMARY BREAST CANCER THERAPY--BIOSTATISTICS CENTERU10CA069651 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2012
$52.1M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
IBCSG STATISTICAL CENTER--A BREAST CANCER STUDY RESOURCEU24CA075362 · NCI · DANA-FARBER CANCER INSTITUTE · PI REGAN, MEREDITH M · 1997 to 2015
$7.5M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
NCI NIH HHS CA077202NCI NIH HHS CA16116NCI NIH HHS CA180821NCI NIH HHS CA21115NCI NIH HHS N01 CA032102NCI NIH HHS U10 CA012027NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA037377NCI NIH HHS U10 CA069651NCI NIH HHS U10 CA069974NCI NIH HHS U10 CA077202NCI NIH HHS U10-CA-12027NCI NIH HHS U10 CA180821NCI NIH HHS U10-CA-37377NCI NIH HHS U10-CA-69651NCI NIH HHS U10-CA-69974NCI NIH HHS U24 CA075362PHS HHS 021039PHS HHS CCSRI 015469
6 · The paper itself

Abstract

backgroundThe combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression (OFS) compared with tamoxifen plus OFS. We present patient-reported outcomes from these trials.

methodsBetween Nov 7, 2003, and April 7, 2011, 4717 premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with 5 years of exemestane plus OFS or tamoxifen plus OFS. Gonadotropin-releasing hormone analogue triptorelin, bilateral oophorectomy, or bilateral ovarian irradiation were used to achieve OFS. Chemotherapy use was optional. Randomisation with permuted blocks was done with the International Breast Cancer Study Group's internet-based system and was stratified by chemotherapy use and status of lymph nodes. Patients completed a quality of life (QoL) form comprising several global and symptom indicators at baseline, every 6 months for 24 months, and then every year during years 3 to 6. Differences in the change of QoL from baseline between the two treatments were tested at 6 months, 24 months, and 60 months with mixed-models for repeated measures for each trial with and without chemotherapy and overall. The analysis was by intention to treat. At the time of analysis, the median follow-up was 5·7 years (IQR 3·7-6·9); treatment and follow-up of patients continue. The trials are registered with ClinicalTrials.gov, as NCT00066703 (TEXT) and NCT00066690 (SOFT).

findingsPatients on tamoxifen plus OFS were more affected by hot flushes and sweats over 5 years than were those on exemestane plus OFS, although these symptoms improved. Patients on exemestane plus OFS reported more vaginal dryness, greater loss of sexual interest, and difficulties becoming aroused than did patients on tamoxifen plus OFS; these differences persisted over time. An increase in bone or joint pain was more pronounced, particularly in the short term, in patients on exemestane plus OFS than patients on tamoxifen plus OFS. Changes in global QoL indicators from baseline were small and similar between treatments over the 5 years.

interpretationOverall, from a QoL perspective, there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS. The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually.

fundingPfizer, International Breast Cancer Study Group, and US National Cancer Institute.

Indexed as

Self ReportAdministration, OralAdultAntineoplastic Agents, HormonalBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleEarly Detection of CancerFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingAntineoplastic Agents, HormonalTamoxifen

Identifiers

PMID26092816
PMCPMC4562429
OpenAlexW1890169097

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.