deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00553410

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer (SOLE)

SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

Sponsor: Breast International Group

Conditions Breast Cancer
Interventions Letrozole
Updated 13 times since 2017 Last updated: Mar 9, 2020 Started: Aug 31, 2007 Primary completion: Apr 30, 2018 Completion: May 15, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Breast Cancer and is currently completed. Breast International Group leads this study, which shows 13 recorded versions since 2007 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Mar 2018 · 14 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Jul 2019 · 5 months · monthly snapshot~Jul 2019 – ~Apr 2020 · 9 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Oct 2022 · 21 months · monthly snapshot~Oct 2022 – ~Dec 2022 · 2 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

Show 8 earlier versions
  1. Oct 2022 — Dec 2022 [monthly]

    Completed PHASE3

  2. Jan 2021 — Oct 2022 [monthly]

    Completed PHASE3

  3. Apr 2020 — Jan 2021 [monthly]

    Completed PHASE3

  4. Jul 2019 — Apr 2020 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  5. Feb 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2017 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Aug 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Breast International Group
  • ETOP IBCSG Partners Foundation
Data source: ETOP IBCSG Partners Foundation

For direct contact, visit the study record on ClinicalTrials.gov .