PMID- 38537155
OWN - NLM
STAT- Publisher
LR  - 20240412
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
DP  - 2024 Mar 27
TI  - Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated 
      Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast 
      Cancer Study.
PG  - JCO2301500
LID - 10.1200/JCO.23.01500 [doi]
AB  - PURPOSE: To compare giredestrant and physician's choice of endocrine monotherapy 
      (PCET) for estrogen receptor-positive, HER2-negative, advanced breast cancer (BC) 
      in the phase II acelERA BC study (ClinicalTrials.gov identifier: NCT04576455). 
      METHODS: Post-/pre-/perimenopausal women, or men, age 18 years or older with 
      measurable disease/evaluable bone lesions, whose disease progressed after 1-2 
      lines of systemic therapy (</=1 targeted, </=1 chemotherapy regimen, prior 
      fulvestrant allowed) were randomly assigned 1:1 to giredestrant (30 mg oral once 
      daily) or fulvestrant/aromatase inhibitor per local guidelines (+luteinizing 
      hormone-releasing hormone agonist in pre-/perimenopausal women, and men) until 
      disease progression/unacceptable toxicity. Stratification was by visceral versus 
      nonvisceral disease, prior cyclin-dependent kinase 4/6 inhibitor, and prior 
      fulvestrant. The primary end point was investigator-assessed progression-free 
      survival (INV-PFS). RESULTS: At clinical cutoff (February 18, 2022; median 
      follow-up: 7.9 months; N = 303), the INV-PFS hazard ratio (HR) was 0.81 (95% CI, 
      0.60 to 1.10; P = .1757). In the prespecified secondary end point analysis of 
      INV-PFS by ESR1 mutation (m) status in circulating tumor DNA-evaluable patients 
      (n = 232), the HR in patients with a detectable ESR1m (n = 90) was 0.60 (95% CI, 
      0.35 to 1.03) versus 0.88 (95% CI, 0.54 to 1.42) in patients with no ESR1m 
      detected (n = 142). Related grade 3-4 adverse events (AEs), serious AEs, and 
      discontinuations due to AEs were balanced across arms. CONCLUSION: Although the 
      acelERA BC study did not reach statistical significance for its primary INV-PFS 
      end point, there was a consistent treatment effect with giredestrant across most 
      key subgroups and a trend toward favorable benefit among patients with 
      ESR1-mutated tumors. Giredestrant was well tolerated, with a safety profile 
      comparable to PCET and consistent with known endocrine therapy risks. Overall, 
      these data support the continued investigation of giredestrant in other studies.
FAU - Martin, Miguel
AU  - Martin M
AUID- ORCID: 0000-0001-9237-3231
AD  - Hospital Gregorio Maranon, Universidad Complutense, GEICAM, CIBERONC, Madrid, 
      Spain.
FAU - Lim, Elgene
AU  - Lim E
AD  - Garvan Institute of Medical Research, St Vincent's Clinical School, University of 
      New South Wales, Darlinghurst, Australia.
FAU - Chavez-MacGregor, Mariana
AU  - Chavez-MacGregor M
AUID- ORCID: 0000-0002-7189-0763
AD  - The University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Bardia, Aditya
AU  - Bardia A
AUID- ORCID: 0000-0003-4885-1157
AD  - Massachusetts General Hospital, Harvard Medical School, Boston, MA.
FAU - Wu, Jiong
AU  - Wu J
AUID- ORCID: 0000-0002-8103-0505
AD  - Fudan University Cancer Institute, Shanghai, China.
FAU - Zhang, Qingyuan
AU  - Zhang Q
AD  - Harbin Medical University Cancer Hospital, Harbin, China.
FAU - Nowecki, Zbigniew
AU  - Nowecki Z
AUID- ORCID: 0000-0001-7706-8191
AD  - Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
FAU - Cruz, Felipe Melo
AU  - Cruz FM
AUID- ORCID: 0000-0002-4558-4850
AD  - Nucleo de Pesquisa e Ensino da Rede Sao Camilo, Sao Paulo, Brazil.
FAU - Safin, Rustem
AU  - Safin R
AUID- ORCID: 0000-0003-0585-7727
AD  - Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic 
      of Tatarstan, Kazan, Russian Federation.
FAU - Kim, Sung-Bae
AU  - Kim SB
AUID- ORCID: 0000-0001-5588-8332
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of 
      Korea.
FAU - Schem, Christian
AU  - Schem C
AD  - Krankenhaus Jerusalem, Mammazentrum Hamburg, Hamburg, Germany.
FAU - Montero, Alberto J
AU  - Montero AJ
AUID- ORCID: 0000-0002-8221-8120
AD  - University Hospitals/Seidman Cancer Center, Case Western Reserve University, 
      Cleveland, OH.
FAU - Khan, Sarah
AU  - Khan S
AD  - Nottingham University Hospitals, City Hospital Campus, Nottingham, United 
      Kingdom.
FAU - Bandyopadhyay, Reeti
AU  - Bandyopadhyay R
AD  - Genentech, Inc, South San Francisco, CA.
FAU - Moore, Heather M
AU  - Moore HM
AUID- ORCID: 0000-0002-7098-3888
AD  - Genentech, Inc, South San Francisco, CA.
FAU - Shivhare, Mahesh
AU  - Shivhare M
AD  - Roche Products Limited, Welwyn Garden City, United Kingdom.
FAU - Patre, Monika
AU  - Patre M
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Martinalbo, Jorge
AU  - Martinalbo J
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
AD  - Inhibrx, La Jolla, CA.
FAU - Roncoroni, Laura
AU  - Roncoroni L
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
AD  - AstraZeneca, Barcelona, Spain.
FAU - Perez-Moreno, Pablo Diego
AU  - Perez-Moreno PD
AD  - Genentech, Inc, South San Francisco, CA.
FAU - Sohn, Joohyuk
AU  - Sohn J
AUID- ORCID: 0000-0002-2303-2764
AD  - Yonsei University College of Medicine, Seoul, Republic of Korea.
CN  - acelERA Breast Cancer Study Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT04576455
PT  - Journal Article
DEP - 20240327
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
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IR  - Aguil G
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IR  - Alfie M
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EDAT- 2024/03/27 18:44
MHDA- 2024/03/27 18:44
CRDT- 2024/03/27 16:03
PHST- 2024/03/27 18:44 [pubmed]
PHST- 2024/03/27 18:44 [medline]
PHST- 2024/03/27 16:03 [entrez]
AID - 10.1200/JCO.23.01500 [doi]
PST - aheadofprint
SO  - J Clin Oncol. 2024 Mar 27:JCO2301500. doi: 10.1200/JCO.23.01500.