Asset profile

Alpelisib (BYL719)

Small molecule

Approvedregulatory verdict

Evidence outlook

Approved — HR+/HER2- Metastatic Breast Cancer

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

track record: Reliable signal

How the evidence outlook works ↗

Upcoming events

(11 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-27 · NCT05563220 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (6)
January 2027 (2)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-01-28 · NCT05038735 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-01-29 · NCT04544189 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

February 2027 (3)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT01872260 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT04524000 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 3Advanced HER2+Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT04208178 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2027 (1)
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-10-08 · NCT05090358 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (1)
July 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2028-07 · NCT05625087 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (2)
July 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-07-01 · NCT05564377 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-10 · NCT05933395 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2031 (1)
June 2031 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2031-06-27 · NCT07679269 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

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Competitive landscape

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