Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2)
A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Sponsor: Novartis Pharmaceuticals
A PHASE3 clinical study on Breast Cancer, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 24 data snapshots since 2012. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
24 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE3
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Sep 2025 — Feb 2026 [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 19 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
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Sep 2020 — Jan 2021 [monthly]
Completed PHASE3
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Jul 2020 — Sep 2020 [monthly]
Completed PHASE3
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Feb 2020 — Jul 2020 [monthly]
Completed PHASE3
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Sep 2019 — Feb 2020 [monthly]
Completed PHASE3
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Jun 2019 — Sep 2019 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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May 2019 — Jun 2019 [monthly]
Active Not Recruiting PHASE3
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Apr 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Feb 2019 — Apr 2019 [monthly]
Active Not Recruiting PHASE3
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Dec 2018 — Feb 2019 [monthly]
Active Not Recruiting PHASE3
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Sep 2018 — Dec 2018 [monthly]
Active Not Recruiting PHASE3
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Aug 2018 — Sep 2018 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE3
Status: Active Not Recruiting → Recruiting
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Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting PHASE3
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Nov 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Jul 2017 — Nov 2017 [monthly]
Active Not Recruiting PHASE3
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May 2017 — Jul 2017 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — May 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Aug 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Angers, France , Arcadia, United States , Athens, Greece , Aviano, Italy , Avignon, France , Baltimore, United States , Bangkok, Thailand , Barcelona, Spain , Barretos, Brazil , Beijing, China and 219 more locations