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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Giredestrant; Drug: LHRH Agonist; Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice)

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación Cenit para la Investigación en Neurociencias
  • Buenos Aires, Argentina, 1417
    • Instituto Angel Roffo
  • Mendoza, Argentina, M5500AYB
    • Fundacion Scherbovsky
  • Rosario, Argentina, S2002KDS
    • Hosp Provincial D. Centenarios
  • San Nicolás, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Kinghorn Cancer Centre
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60810-180
      • Pronutrir - suporte nutricional e quimioterapia ltda.
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Santa Casa de Misericordia de Porto Alegre
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01317-001
      • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
• China
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Guangzhou, China, 510060
    • Sun Yet-sen University Cancer Center
  • Linyi, China, 276034
    • Linyishi Cancer Hospital
  • Nanchang, China, 330000
    • The Third Hospital of Nanchang
  • Shanghai, China, 200120
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• Germany
  • Aschaffenburg, Germany, 63739
    • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
  • Berlin, Germany, 14169
    • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
  • Hamburg, Germany, 20357
    • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
  • Paderborn, Germany, 33098
    • St. Vincenz-Krankenhaus Paderborn
  • Stralsund, Germany, 18439
    • Gynäkologie Kompetenzzentrum
• Israel
  • Ashdod, Israel
    • Assuta Medical Center- Ashdod
  • Jerusalem, Israel, 9112000
    • Hadassah Ein Karem Hospital
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
• Poland
  • Bialystok, Poland, 15-027
    • Bialostockie Centrum Onkologii
  • Gliwice, Poland, 44-102
    • Narodowy Instytut Onkologii Odzia? w Gliwicach
  • Warsaw, Poland, 02-781
    • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
• Russia
  • Krasnodar, Russia, 350040
    • Clinical Oncology Centre # 1
  • Samara, Russia, 443011
    • Multidisciplinary clinic Reaviz
  • Volgograd, Russia, 400138
    • Volgograd Regional Clinical Oncology Dispensary
  • Yaroslavl, Russia, 150040
    • Regional Clinical Oncology Hospital
  • Krasnodarskiy Kray
    • Krasnoyarsk, Krasnodarskiy Kray, Russia, 660133
      • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
  • Leningrad
    • Pesochny, Leningrad, Russia, 197758
      • Petrov Research Inst. of Oncology
  • Moscow Oblast
    • Moskva, Moscow Oblast, Russia, 115478
      • Blokhin Cancer Research Center
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russia, 603081
      • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • St. Petersburg SHI "City Clinical Oncology Dispensary"
  • Tatarstan Republic
    • Kazan', Tatarstan Republic, Russia, 420029
      • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre
  • Singapore, Singapore, 119228
    • National University Hospital
• South Africa
  • Bloemfontein, South Africa, 9301
    • Iatros International
  • Pretoria, South Africa, 0081
    • Eastleigh Breast Care Centre
• South Korea
  • Dongnam-gu, Cheonan-si, South Korea, 31151
    • Soon Chun Hyang University Cheonan Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Seoul, South Korea, 06591
    • Seoul St Mary's Hospital
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung Uni Hospital
  • Tainan, Taiwan, 710
    • Chi-Mei Medical Centre
  • Taipei, Taiwan, 00112
    • Veterans General Hospital
  • Taoyuan Hsien, Taiwan, 333
    • Chang Gung Memorial Hosipital at Linkou
• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Chang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hosp
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital
  • Antalya, Turkey (Türkiye), 07020
    • Memorial Antalya Hospital
  • Diyarbakır, Turkey (Türkiye), 21280
    • Dicle University Faculty of Medicine
  • Istanbul, Turkey (Türkiye), 34384
    • Prof. Dr. Cemil Tascioglu City Hospital
  • Istanbul, Turkey (Türkiye), 34000
    • Kartal Dr Lutfi Kirdar Sehir Hastanesi
  • Izmir, Turkey (Türkiye), 35360
    • Izmir Ataturk Training and Research Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Medikal Park Samsun
• Ukraine
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • Kyiv, Ukraine, 04107
    • MI Kyiv Regional Council Kyiv Regional Oncological Dispensary
  • Sumy, Ukraine, 40005
    • RCI Sumy Regional Clinical Oncological Dispensary
  • KIEV Governorate
    • Zhytomyr, KIEV Governorate, Ukraine
      • Zhytomyr Regional Oncology Center
• United Kingdom
  • Harlow, United Kingdom, CM20 1QX
    • Princess Alexandra Hospital
  • London, United Kingdom, SE1 9RT
    • Guys & St Thomas Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Peterborough, United Kingdom, PE3 9GZ
    • Peterborough City Hospital
• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC - Marietta
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Northwest Cancer Specialists - Portland (SW Barnes Rd)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Giredestrant	Drug: Giredestrant; Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.; Other Names: GDC-9545; RO7197597; RG6171; Drug: LHRH Agonist; Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Active Comparator: Physician Choice of Endocrine Monotherapy; The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.	Drug: LHRH Agonist; Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.; Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice); Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	PFS was defined as the Kaplan-Meier estimate of time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Kaplan-Meier methodology was used to estimate median PFS. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley. Participants without the occurrence of disease progression or death as of the clinical cutoff were censored at the time of the last tumor assessment prior to the clinical cutoff or at the time of randomization plus 1 day for those without post-baseline assessment.	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (duration of follow-up, median [range]: 7.9 [0.0-14.1] months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) is defined as the Kaplan-Meier estimate of time from randomization to death from any cause. Kaplan-Meier methodology was used to estimate median OS. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley. Analysis strata are: Site of disease, Prior treatment with CDK4/6 inhibitor and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression. Data for participants who were alive at the time of the analysis data cutoff were censored at the last date they were known to be alive. Data from participants without postbaseline information were censored at the date of randomization plus 1 day.	From randomization to death from any cause (duration of follow-up, median [range]: 34.6 [0.0-41.8] months)
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1	The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart. Per RECIST v1.1, CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.	From randomization until disease progression or death (up to approximately 15 months)
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1	DOR is defined as the Kaplan-Meier estimate of time from the first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). Objective response rate is defined as the percentage of participants with a CR or PR on two consecutive occasions at least 4 weeks apart. Per RECIST v1.1, CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.	From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 15 months)
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1	The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a CR or PR. Per RECIST v1.1, CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.	From randomization until disease progression or death (up to approximately 15 months)
Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor (ESR1) Mutation Status	PFS was defined as the Kaplan-Meier estimate of time from randomization to the first occurrence of disease progression determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Investigator-assessed PFS was analyzed in subgroups categorized by baseline ESR1 mutation status (i.e., with or without ESR1 mutation at baseline) from plasma circulating tumor deoxyribonucleic acid (ctDNA). Participants without the occurrence of disease progression or death as of the clinical cutoff were censored at the time of the last tumor assessment prior to the clinical cutoff or at the time of randomization plus 1 day for those without post-baseline assessment.	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (duration of follow-up, median [range]: 7.9 [0.0-14.1] months)
Time to Deterioration (TTD) in Pain Severity, Based on the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire	TTD in pain severity is defined as time to first documented ≥2-point increase from Baseline in the "Worst Pain" item from the BPI-SF Questionnaire held for at least two consecutive cycles or an initial ≥2-point worsening followed by death or treatment discontinuation within 3 weeks from the last assessment. The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 10-point numeric rating scale, with 0="No pain", "No interference" to 10="Pain as bad as you can imagine", "Highest imaginable interference". A lower score indicates improvement. 95% CI for median was computed using the method of Brookmeyer and Crowley. Strata are: Site of disease, Prior treatment with CDK4/6 inhibitor, and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression.	From Baseline until treatment discontinuation (up to approximately 41 months)
TTD in Pain Presence and Interference, Based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain Scale Score	TTD in pain presence and interference is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed pain scale score (0-100 scale) held for at least 2 consecutive cycles or an initial ≥10-point worsening followed by death or treatment discontinuation within 3 weeks from the last assessment. EORTC QLQ-C30 is a patient-reported measure with 30 questions assessing 5 aspects of functioning, 3 symptom scales, global health and quality of life, and 6 single items with a recall period of the previous week. The pain scale is scored on a 4-point scale (1=Not at All to 4=Very Much); higher scores indicate worse pain symptoms. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Strata are: Site of disease, Prior treatment with CDK4/6 inhibitor, and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression.	From Baseline until treatment discontinuation (up to approximately 41 months)
TTD in Physical Functioning (PF), Based on the EORTC QLQ-C30 PF Scale Score	TTD in PF is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed PF scale score (0-100 scale) held for at least 2 consecutive cycles or an initial ≥10-point worsening followed by death or treatment discontinuation within 3 weeks from the last assessment. EORTC QLQ-C30 is a patient-reported measure with 30 questions assessing 5 aspects of functioning, 3 symptom scales, global health and quality of life, and 6 single items with a recall period of the previous week. The PF scale has 5 questions scored on a 4-point scale (1=Not at All to 4=Very Much); higher scores indicate better function. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Strata are: Site of disease, Prior treatment with CDK4/6 inhibitor, and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression.	From Baseline until treatment discontinuation (up to approximately 41 months)
TTD in Role Functioning (RF), Based on the EORTC QLQ-C30 RF Scale Score	TTD in RF is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed RF scale score (0-100 scale) held for at least 2 consecutive cycles or an initial ≥10-point worsening followed by death or treatment discontinuation within 3 weeks from the last assessment. EORTC QLQ-C30 is a patient-reported measure with 30 questions assessing 5 aspects of functioning, 3 symptom scales, global health and quality of life, and 6 single items with a recall period of the previous week. The RF is scored on a 4-point scale (1=Not at All to 4=Very Much); higher scores indicate better function. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Strata are: Site of disease, Prior treatment with CDK4/6 inhibitor, and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression.	From Baseline until treatment discontinuation (up to approximately 41 months)
TTD in Global Health Status and Quality of Life (GHS/QoL), Based on the EORTC QLQ-C30 GHS/QoL Scale Score	TTD in GHS/QoL is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed RF scale score (0-100 scale) held for at least 2 consecutive cycles or an initial ≥10-point worsening followed by death or treatment discontinuation within 3 weeks from the last assessment. EORTC QLQ-C30 is a patient-reported measure with 30 questions assessing 5 aspects of functioning, 3 symptom scales, global health and quality of life, and 6 single items with a recall period of the previous week. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent); higher scores indicate better QoL. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Strata are: Site of disease, Prior treatment with CDK4/6 inhibitor, and Prior treatment with fulvestrant. Hazard ratios were estimated by Cox regression.	From Baseline until treatment discontinuation (up to approximately 41 months)
Number of Participants With Adverse Events (AEs), Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)	An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; recurrence of an intermittent medical condition; any deterioration in a laboratory value or other clinical test; AEs that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.	From first dose until 30 days after final dose of study drug (up to approximately 55 months)
Number of Participants With Vital Sign Abnormalities Over the Course of the Study	Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.	Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to approximately 55 months)
Number of Participants With Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study	Hematology parameters include white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, other cells).	Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to approximately 55 months)
Number of Participants With Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study	Biochemistry parameters include bicarbonate or total carbon dioxide, sodium, potassium, chloride, glucose, blood urea nitrogen (BUN) or urea, creatinine, total protein, albumin, phosphate, calcium, total and direct bilirubin, alkaline phosphatase level test (ALP), Alanine transaminase (ALT), aspartate aminotransferase (AST), urate, and lactate dehydrogenase (LDH).	Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to approximately 55 months)
Plasma Concentration of Giredestrant at Specified Timepoints		Cycle 1 Day 1 3-hours postdose, Cycle 2 Day 1 predose, Cycle 2 Day 1 3-hour postdose, Cycle 3 Day 1 predose

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): February 18, 2022
• Study Completion (Estimated): August 25, 2027

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant; Gonadotropin-Releasing Hormone; giredestrant
• Other Study ID Numbers: WO42312; 2020-001984-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No