trialsTrialActive

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

A phase 2 trial of Giredestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) is a phase 2 interventional study registered as NCT04576455 by Hoffmann-La Roche, with 303 participants enrolled, started 2020-11-27 and due to reach its primary completion in 2022-02-18. Interventions recorded: Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice) and LHRH Agonist. Results have been posted on the registry.

Setting

A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Phase

Phase 2

Sponsor

Hoffmann-La Roche

Registry

Started

2020-11-27

Reported

2023

Enrolled

303 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

303 enrolled

Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)primarysurrogate endpoint

Median 5.6 vs 5.4 months with Giredestrant compared with Physician's Choice of Endocrine Monotherapy; about 0.2 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.6 to 1.1).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Overall Survival (OS)survival endpoint

Median 27.5 vs 29.8 months with Giredestrant compared with Physician's Choice of Endocrine Monotherapy; about 2.3 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 16 percent higher chance of the event at any given time (hazard ratio 1.16, likely range 0.85 to 1.6).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Caveats

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
These results apply to the people the trial enrolled: A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer. People in a different situation may not see the same effect.
The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

303 enrolled.

Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)primary

HR 0.81 (0.6 to 1.1) · p = 0.1757

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95% CI 4.93 to 7.36; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication · 95% CI 3.71 to 5.55

Overall Survival (OS)

HR 1.16 (0.85 to 1.6) · p = 0.3446

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95% CI 23.20 to 32.69; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication · 95% CI 26.78 to NA

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)primary	Giredestrant	151	5.55 months	0.81 (0.6 to 1.1)	0.1757	link
	Physician's Choice of Endocrine Monotherapy	152	5.36 months	0.81 (0.6 to 1.1)	0.1757	link
Overall Survival (OS)	Giredestrant	151	27.5 months	1.16 (0.85 to 1.6)	0.3446	link
Overall Survival (OS)	Physician's Choice of Endocrine Monotherapy	152	29.77 months	1.16 (0.85 to 1.6)	0.3446	link

Key papers

rctJournal of Clinical Oncology 202470 citations

Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study

This is the paper Europe PMC returns for registry id NCT04576455 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.

Connected

Similar pages

cancers

HR-positive / HER2-negative breast cancer

technologies

Endocrine therapy (SERMs, AIs, SERDs)

drugs

ApprovedInjectable SERD

Fulvestrant · Faslodex

Phase 3Oral SERD

companies

Flatiron Health (Roche)

key papers

Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study