Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Study acronym: TEXT
StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 405 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv405
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2025 to Oct 23, 2024
    v404
  3. Publications: details revised at 1 of 14 entriesv403
  4. Re-verified, no change to tracked fieldsv402
  5. Study completion date: Dec 2020 to Dec 2025v401
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Jun 2014 to Mar 11, 2011
    • Start date: Aug 2003 to Nov 3, 2003
    • Study completion date: Jun 2020 to Dec 2020
    v400
  2. 2 versions Re-verified since Mar 9, 2020, no change to tracked fieldsv398-v399
  3. Secondary endpoints: details revised at 1 of 3 entriesv397
  4. Site details revised at 2 of 228 sitesv396
  5. Re-verified, no change to tracked fieldsv395
  6. Results first posted: Apr 5, 2016v394 Show 7 more changesShow less
    • Primary completion date changed from estimate of Jun 2015 to Jun 2014
    • Study completion date: Jun 2015 to Jun 2020
    • Interventions: exemestane (Drug), tamoxifen citrate (Drug) to exemestane (Drug), tamoxifen (Drug), triptorelin (Drug)
    • Secondary endpoints: 4 to 3
    • Primary endpoint revised
    • Study description shortened, about 155 words
    • Publications: 12 to 14
  7. Primary completion date: Dec 2014 to Jun 2015
    • Study completion date: Jun 2015
    • Secondary endpoints: 8 to 4
    v393
  8. Study sites revised (228)v392
  9. Study sites revised (228)v391
  10. Primary completion date: Jan 2014 to Dec 2014v390
  11. Lead sponsor: National Cancer Institute (NCI) to ETOP IBCSG Partners Foundationv389 Show 10 more changesShow less
    • Primary completion date: Dec 2031 to Jan 2014
    • Primary endpoint revised
    • Enrollment target: estimated 2639 to confirmed 2672
    • Study sites: 245 to 228
    • Interventions: exemestane (Drug), laboratory biomarker analysis (Other), quality-of-life assessment (Procedure), tamoxifen citrate (Drug), triptorelin… to exemestane (Drug), tamoxifen citrate (Drug)
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 16 words
    • Collaborators: 1 to 2
    • Publications: 11 to 12
  12. Lead sponsor: ETOP IBCSG Partners Foundation to National Cancer Institute (NCI)v388 Show 10 more changesShow less
    • Primary completion date: Sep 2013 to Dec 2031
    • Primary endpoint revised
    • Enrollment target: 2672 to 2639
    • Study sites: 228 to 245
    • Interventions: exemestane (Drug), tamoxifen citrate (Drug) to exemestane (Drug), laboratory biomarker analysis (Other), quality-of-life assessment (Procedure), tamoxifen citrate (Drug), triptorelin…
    • Eligibility criteria shortened, about 84 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 16 words
    • Collaborators: 2 to 1
    • Publications: 12 to 11
  13. Enrollment target: estimated 2639 to confirmed 2672v387
  14. Primary completion date: Jul 2007 to Sep 2013
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 7 words
    v386
  15. Re-verified, no change to tracked fieldsv385
  16. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 228 of 228 sites
    v384
  17. Study sites: 227 to 228v383
  18. Study sites: 226 to 227v382
  19. Study sites: 225 to 226v381
  20. Study sites: 224 to 225v380
  21. Study sites: 225 to 224v379
  22. Study sites: 226 to 225v378
  23. Study sites: 228 to 226v377
  24. Study sites: 227 to 228v376
  25. Study sites: 225 to 227v375
  26. Study sites: 226 to 225v374
  27. Study sites: 227 to 226v373
  28. Study sites: 226 to 227v372
  29. Study sites: 227 to 226v371
  30. Study sites: 228 to 227v370
  31. Study sites: 226 to 228v369
  32. Re-verified, no change to tracked fieldsv368
  33. Study sites: 222 to 226v367
  34. Study sites: 225 to 222v366
  35. Study sites: 226 to 225v365
  36. Study sites revised (226)v364
  37. Study sites: 227 to 226v363
  38. Study sites: 228 to 227v362
  39. Study sites: 229 to 228v361
  40. Study sites: 228 to 229v360
  41. Study sites: 227 to 228v359
  42. Study sites: 226 to 227v358
  43. Study sites: 225 to 226v357
  44. Study sites: 230 to 225v356
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Trial Details
NCT Number NCT00066703
Lead Sponsor ETOP IBCSG Partners Foundation
Collaborators: National Cancer Institute (NCI), Breast International Group
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 2,672 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov