Asset profile

Giredestrant

Small molecule

Phase 3underway

Evidence outlook · registrational

HR+/HER2- Metastatic Breast Cancer: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2027-02-19.

NCT04436744: This was a randomized but unblinded trial of 221 patients using a tumor biomarker (Ki67), rather than a hard clinical outcome such as tumor response or survival, as its primary measure; the giredestrant combination produced a statistically significant reduction in this biomarker compared with the anastrozole combination.

How the evidence outlook works ↗

Upcoming events

(7 total)

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

2027 (2)
February 2027 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-02-19 · NCT06065748 · 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 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-10-31 · NCT05296798 · CT.gov ↗
What to watch

Research analysis

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

2028 (2)
June 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-06-30 · NCT05708235 · CT.gov ↗
What to watch

Research analysis

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

August 2028 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-08-31 · NCT07100106 · CT.gov ↗
What to watch

Research analysis

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

2029 (1)
May 2029 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05-30 · NCT04802759 · CT.gov ↗
What to watch

Research analysis

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

2030 (1)
September 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
What to watch

Research analysis

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

2032 (1)
June 2032 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2032-06-30 · NCT07541079 · 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 ↗

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