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)
Summary
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.
Timeline
- Start
- 2020-11-27
- Primary completion
- 2022-02-18
- Completion
- 2027-08-25
Outcome
Missed primary endpoint
registry analysis (superiority test); Giredestrant vs Physician's Choice of Endocrine Monotherapy; p = 0.1757; Hazard Ratio (HR) 0.81 (95% CI 0.60 to 1.10); Log Rank NCT04576455 ↗
paper Although the acelERA BC study did not reach statistical significance for its primary INV-PFS end point PMID 38537155 ↗
release “the phase II acelERA trial on giredestrant did not meet its primary endpoint” roche.com ↗
Publications
- Martin M, Lim E, Chavez-MacGregor M, Bardia A, Wu J, Zhang Q, Nowecki Z, Cruz FM, Safin R, Kim SB, Schem C, Montero AJ, Khan S, Bandyopadhyay R, Moore HM, Shivhare M, Patre M, Martinalbo J, Roncoroni L, Perez-Moreno PD, Sohn J; acelERA Breast Cancer Study Investigators. Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study. J Clin Oncol. 2024 Jun 20;42(18):2149-2160. doi: 10.1200/JCO.23.01500. Epub 2024 Mar 27.
- Malhi V, Nowicka M, Chen YC, Agarwal P, Waldvogel M, Lien YTK, Hafner M, Perez-Moreno P, Moore HM, Yu J. UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure. Cancer Chemother Pharmacol. 2024 Jul;94(1):117-122. doi: 10.1007/s00280-023-04634-4. Epub 2024 Feb 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fulvestrant | Small molecule | — | — |
| Subject | Giredestrant | Small molecule | 30 mg | Oral |