Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Study acronym: SOFT
StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 572 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv572
  2. Site details revised at 3 of 500 sitesv571
  3. Primary completion date: Nov 6, 2024 to May 2014v570
  4. Primary completion date: May 2014 to Nov 6, 2024
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2025 to Nov 6, 2024
    v569
  5. Publications: details revised at 2 of 13 entriesv568
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv567
  2. Primary completion date changed from estimate of Dec 2031 to May 2014
    • Study completion date: Dec 2031 to Dec 2025
    v566
  3. Start date: Aug 2003 to Dec 17, 2003v565
  4. Study completion date: Dec 2031
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 3 of 500 sites
    v564
  5. Results first posted: Sep 22, 2016v563 Show 10 more changesShow less
    • Primary completion date: Jan 2014 to Dec 2031
    • Study sites: 263 to 500
    • Interventions: exemestane (Drug), oophorectomy (Procedure), radiation therapy (Radiation), tamoxifen citrate (Drug), triptorelin (Drug) to Exemestane (Drug), Laboratory Biomarker Analysis (Other), Oophorectomy (Procedure), Quality-of-Life Assessment (Other), Radiation Therapy…
    • Eligibility criteria expanded, about 544 words
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    • Study description shortened, about 146 words
    • Collaborators reordered
    • Publications: 14 to 13
    • Study title revised
  6. Primary completion date: Sep 2013 to Jan 2014v562
  7. Re-verified, no change to tracked fieldsv561
  8. Enrollment target: estimated 3000 to confirmed 3066v560
  9. Primary completion date: Jul 2010 to Sep 2013
    • Primary endpoint revised
    • Secondary endpoints revised (3)
    • Study description expanded, about 8 words
    v559
  10. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (263)
    v558
  11. Re-verified, no change to tracked fieldsv557
  12. Study sites revised (263)v556
  13. Eligibility criteria revised
    • Study description revised
    v555
  14. Study sites: 264 to 263v554
  15. Study sites: 265 to 264v553
  16. Study sites: 266 to 265
    • Study description expanded, about 38 words
    v552
  17. Study sites: 263 to 266v551
  18. Study sites: 264 to 263v550
  19. Study sites: 259 to 264v549
  20. Study sites: 258 to 259v548
  21. Study sites: 256 to 258v547
  22. Study sites: 257 to 256v546
  23. Site contacts updated at 1 of 257 sitesv545
  24. Study sites: 256 to 257v544
  25. Study sites: 257 to 256v543
  26. Study sites: 188 to 257v542
  27. Study sites: 190 to 188v541
  28. Study sites: 189 to 190v540
  29. Study sites: 188 to 189v539
  30. Study sites: 186 to 188v538
  31. Study sites: 188 to 186v537
  32. Study sites: 185 to 188v536
  33. Study sites: 182 to 185v535
  34. Study sites: 181 to 182v534
  35. Study sites: 180 to 181v533
  36. Study sites revised (180)v532
  37. Study sites: 179 to 180v531
  38. Study sites revised (179)v530
  39. Study sites: 180 to 179v529
  40. Study sites: 179 to 180v528
  41. Study sites: 180 to 179v527
  42. Study sites: 181 to 180v526
  43. Study sites: 180 to 181v525
  44. Study sites: 240 to 180v524
  45. Study sites: 557 to 240v523
  • 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 tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
Trial Details
NCT Number NCT00066690
Lead Sponsor ETOP IBCSG Partners Foundation
Collaborators: Breast International Group, Cancer and Leukemia Group B, National Cancer Institute (NCI), NSABP Foundation Inc, NCIC Clinical Trials Group, North Central Cancer Treatment Group, SWOG Cancer Research Network
Conditions
(from sponsor)		 Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
Related terms Breast Neoplasms
Enrollment 3,066 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov