deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT01077154

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

Sponsor: Amgen

Conditions Breast Cancer
Interventions Denosumab Placebo
Updated 18 times since 2017 Last updated: Sep 1, 2021 Started: Jun 2, 2010 Primary completion: Aug 31, 2017 Completion: Mar 26, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Terminated: Amgen decision following Primary Analysis. Not due to safety reason

Other terminated trials from Amgen

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Other Breast Cancer trials with similar outcome

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A PHASE3 clinical study on Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Amgen and has accumulated 18 data snapshots since 2010. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~May 2018 · 5 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~May 2019 · 6 months · monthly snapshot~May 2019 – ~Mar 2020 · 10 months · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Mar 2024 · 29 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

18 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Mar 2024 — Jul 2024 [monthly]

    Terminated PHASE3

▶ Show 13 earlier versions

  1. Oct 2021 — Mar 2024 [monthly]

    Terminated PHASE3

  2. Jan 2021 — Oct 2021 [monthly]

    Terminated PHASE3

  3. Mar 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  4. May 2019 — Mar 2020 [monthly]

    Terminated PHASE3

  5. Nov 2018 — May 2019 [monthly]

    Terminated PHASE3

  6. Jun 2018 — Nov 2018 [monthly]

    Terminated PHASE3

  7. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  8. Dec 2017 — May 2018 [monthly]

    Active Not Recruiting PHASE3

  9. Oct 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  10. Sep 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE3

  11. Aug 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

  12. Feb 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE3

  13. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jun 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
  • Daiichi Sankyo
Data source: Amgen

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

Study Locations

A Coruña, Spain , Abilene, United States , Ahilyanagar, India , Akashi-shi, Japan , Alcorcón, Spain , Alhambra, United States , Amsterdam, Netherlands , Anaheim, United States , Ancona, Italy , Angers, France and 379 more locations