deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT01783444

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer. (BOLERO-6)

A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.

Sponsor: Novartis Pharmaceuticals

Conditions Breast Cancer
Interventions Capecitabine Everolimus Exemestane
Updated 16 times since 2017 Last updated: Feb 19, 2021 Started: Feb 26, 2013 Primary completion: Jul 2, 2018 Completion: Jul 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Breast Cancer, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 16 data snapshots since 2013. 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 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jan 2021 · 20 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jul 2024 · 40 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Mar 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Mar 2021 [monthly]

    Completed PHASE2

▶ Show 11 earlier versions

  1. May 2019 — Jan 2021 [monthly]

    Completed PHASE2

  2. Apr 2019 — May 2019 [monthly]

    Completed PHASE2

  3. Mar 2019 — Apr 2019 [monthly]

    Completed PHASE2

  4. Dec 2018 — Mar 2019 [monthly]

    Completed PHASE2

  5. Sep 2018 — Dec 2018 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  6. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  7. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE2

  8. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  9. Oct 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE2

  10. Feb 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE2

  11. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Feb 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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

Study Locations

Aarhus, Denmark , Adana, Turkey (Türkiye) , Arequipa, Peru , Arkhangelsk, Russia , Barcelona, Spain , Beirut, Lebanon , Budapest, Hungary , Burlington, United States , CABA, Argentina , Charlottesville, United States and 70 more locations