Clinical trial · Interventional
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant or an Aromatase Inhibitor (Physician Choice) | Drug | — | UNRESOLVED |
| Giredestrant | Drug | — | UNRESOLVED |
| LHRH Agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Giredestrant
- interventionNames
- Drug: Giredestrant
- Drug: LHRH Agonist
- type
- ACTIVE_COMPARATOR
- label
- Physician Choice of Endocrine Monotherapy
- description
- The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
- interventionNames
- Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice)
- Drug: LHRH Agonist
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are postmenopausal or premenopausal/perimenopausal * For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment * Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * Documented ER-positive tumor and HER2-negative tumor, assessed locally * Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting * Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization * Treatment with any investigational therapy within 28 days prior to randomization * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications * Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Active cardiac disease or history of cardiac dysfunction * Pregnant or breastfeeding
References
Publications (2)
- DERIVEDMartin 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. PMID 38537155
- DERIVEDMalhi 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. PMID 38305868