Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated August 28, 2024 (before its estimated September 15, 2024 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2024); last known: Active, Not Recruiting
  2. Trial status: Active, Not Recruiting to Unknown
    • Study sites: 2 to 1
    • Primary completion date: Jun 15, 2024 to Sep 15, 2024
    • Study completion date: Jun 15, 2024 to Oct 15, 2024
    v47
  3. Primary and study completion dates: Mar 15, 2024 to Jun 15, 2024v46
  4. Primary and study completion dates: Dec 15, 2023 to Mar 15, 2024v45
  5. Primary and study completion dates: Jun 15, 2023 to Dec 15, 2023v44
Show 42 earlier versionsHide 42 earlier versions
  1. Primary and study completion dates: Dec 15, 2022 to Jun 15, 2023v43
  2. Primary completion date: Aug 15, 2022 to Dec 15, 2022v42
  3. Primary completion date: Jun 15, 2022 to Aug 15, 2022v41
  4. Primary completion date: Dec 15, 2021 to Jun 15, 2022
    • Study completion date: Dec 15, 2021 to Dec 15, 2022
    v40
  5. Primary and study completion dates: Sep 2019 to Dec 15, 2021v39
  6. Re-verified, no change to tracked fieldsv38
  7. Primary and study completion dates: Sep 2018 to Sep 2019v37
  8. Primary completion date: Sep 2017 to Sep 2018
    • Study completion date: Sep 2018
    • Start date: Feb 2004 to Mar 11, 2004
    v36
  9. Primary completion date: Jul 2016 to Sep 2017v35
  10. Primary completion date: Dec 2012 to Jul 2016
    • Trial status: Completed to Active, Not Recruiting
    v34
  11. Trial status: Active, Not Recruiting to Completedv33 Show 6 more changesShow less
    • Enrollment target: estimated 10 to confirmed 11
    • Primary completion date changed from estimate of Feb 2013 to Dec 2012
    • Interventions: deslorelin (Drug), therapeutic estradiol (Biological), therapeutic testosterone (Drug) to active surveillance (Other), deslorelin (Drug), laboratory biomarker analysis (Other), quality-of-life assessment (Procedure), therapeutic…
    • Eligibility criteria shortened, about 24 words
    • Study description shortened, about 48 words
    • Study arms: 0 to 2
  12. Primary completion date: Dec 2011 to Feb 2013v32
  13. Re-verified, no change to tracked fieldsv31
  14. Lead sponsor: Beckman Research Institute to City of Hope Medical Center
    • Primary completion date: Dec 2008 to Dec 2011
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v30
  15. Re-verified, no change to tracked fieldsv29
  16. Interventions: deslorelin (Drug), therapeutic estradiol (Drug), therapeutic testosterone (Drug) to deslorelin (Drug), therapeutic estradiol (Biological), therapeutic testosterone (Drug)v28
  17. 5 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv23-v27
  18. Interventions: androgen therapy (Procedure), chemoprevention (Procedure), deslorelin (Drug), estrogen therapy (Procedure), releasing hormone agonist… to deslorelin (Drug), therapeutic estradiol (Drug), therapeutic testosterone (Drug)v22
  19. Primary completion date: Dec 2008v21
  20. Start date: Feb 2004v20
  21. Interventions: Intervention/procedure (Procedure), androgen therapy (Procedure), cancer prevention (Procedure), chemoprevention (Procedure), deslorelin… to androgen therapy (Procedure), chemoprevention (Procedure), deslorelin (Drug), estrogen therapy (Procedure), releasing hormone agonist…v19
  22. Interventions: androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)… to Intervention/procedure (Procedure), androgen therapy (Procedure), cancer prevention (Procedure), chemoprevention (Procedure), deslorelin…v18
  23. Site contacts updated at 1 of 2 sitesv17
  24. 2 versions Re-verified since Apr 18, 2007, no change to tracked fieldsv15-v16
  25. Interventions: androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)… to androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)…v14
  26. Study Status, Eligibilityv13
  27. 3 versions Re-verified since Jan 5, 2007, no change to tracked fieldsv10-v12
  28. Enrollment target: 10v9
  29. 3 versions Re-verified since May 23, 2006, no change to tracked fieldsv6-v8
  30. Interventions: androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)… to androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)…v5
  31. Site details revised at 1 of 2 sitesv4
  32. Interventions: androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)… to androgen therapy (Procedure), cancer prevention intervention (Procedure), chemoprevention of cancer (Procedure), deslorelin (Drug)…v3
  33. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women. PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
Trial Details
NCT Number NCT00080756
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
Related terms Breast Neoplasms
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov