Back to resultsA 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)
Primary Purpose
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Giredestrant
Fulvestrant or an Aromatase Inhibitor (Physician Choice)
LHRH Agonist
Sponsored by
About this trial
This is an interventional treatment trial for Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Northwest Georgia Oncology Centers PC - Marietta
- Illinois Cancer Specialists
- Ashland-Bellefonte Cancer Center
- St. Vincent Frontier Cancer Center
- University Hospitals Seidman Cancer Center
- Northwest Cancer Specialists - Portland (SW Barnes Rd)
- Texas Oncology Cancer Center
- Texas Oncology - El Paso
- Texas Oncology - Houston (Gessner)
- Texas Oncology- Northeast Texas
- Fundación CENIT para la Investigación en Neurociencias
- Instituto Angel Roffo
- Fundación Scherbovsky; General Department
- Hosp Provincial D. Centenarios; Oncology Dept
- Organizacion Medica de Investigacion
- Kinghorn Cancer Centre; St Vincents Hospital
- Sunshine Hospital
- Pronutrir - suporte nutricional e quimioterapia ltda.
- Hospital de Caridade de Ijui; Oncologia
- Santa Casa de Misericordia de Porto Alegre
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
- Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
- The First Hospital of Jilin University
- Sun Yet-sen University Cancer Center
- Harbin Medical University Cancer Hospital
- Linyishi Cancer Hospital
- The Third Hospital of Nanchang
- Fudan University Shanghai Cancer Center
- Tianjin Cancer Hospital
- Hubei Cancer Hospital
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
- Zhejiang Cancer Hospital
- Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
- Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
- Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
- St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
- Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
- Assuta Medical Center- Ashdod; Oncology
- Hadassah Ein Karem Hospital; Oncology Dept
- Meir Medical Center; Oncology
- Soon Chun Hyang University Cheonan Hospital
- National Cancer Center
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital
- Seoul St Mary's Hospital
- Samsung Medical Center
- Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
- Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
- Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
- Blokhin Cancer Research Center; Combined Treatment
- Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
- St. Petersburg SHI "City Clinical Oncology Dispensary"
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
- Clinical Oncology Centre # 1; Chemotherapy Dept
- Multidisciplinary clinic Reaviz
- Petrov Research Inst. of Oncology
- Volgograd Regional Clinical Oncology Dispensary
- Regional Clinical Oncology Hospital
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
- National Cancer Centre; Medical Oncology
- Iatros International
- Cancercare Langenhoven Drive Oncology Centre
- Eastleigh Breast Care Centre
- Changhua Christian Hospital; Dept of Surgery
- National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
- Chi-Mei Medical Centre; Hematology & Oncology
- VETERANS GENERAL HOSPITAL; Department of General Surgery
- Chang Gung Memorial Hosipital at Linkou
- Chulalongkorn Hospital; Medical Oncology
- Rajavithi Hospital; Division of Medical Oncology
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
- Songklanagarind Hospital; Department of Oncology
- Memorial Ankara Hastanesi
- Ankara City Hospital; Oncology
- Memorial Antalya Hospital
- Dicle University Faculty of Medicine
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
- Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
- Katip Celebi University Ataturk Training and Research Hospital; Oncology
- Medikal Park Samsun
- Zhytomyr Regional Oncology Center
- Kyiv City Clinical Oncological Center
- MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
- RCI Sumy Regional Clinical Oncological Dispensary
- Princess Alexandra Hospital; Oncology Department
- Guys & St Thomas Hospital; Department of Oncology
- Nottingham City Hospital; Oncology
- Peterborough City Hospital; Oncology Research Department 018
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Giredestrant
Physician Choice of Endocrine Monotherapy
Arm Description
The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
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.
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
DOR is defined as the 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.
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.
Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor 1 (ESR1) Mutation Status
PFS was defined as the 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).
Time to Deterioration (TTD) in Pain Severity
TTD in pain severity is defined as time to first documented ≥2-point increase from Baseline in the "Worst Pain" item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire. 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.
TTD in Pain Presence and Interference, Defined as Time to First Documented ≥10-Point Increase From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Linearly Transformed Pain Scale Score
EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The functioning and symptoms items are scored on a 4-point scale that ranges from 1=not at all to 4=very much. The Pain scale is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate worse pain symptoms.
TTD in Physical Functioning (PF)
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. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The PF scale has 5 questions about participants' physical functioning and is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level (better physical function).
TTD in Role Functioning (RF)
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. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The RF scale is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate better functioning/support.
TTD in Global Health Status and Quality of Life (GHS/QoL)
TTD in GHS/QoL is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed GHS/QoL scale score. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a better QoL.
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.
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.
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).
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).
Plasma Concentration of Giredestrant at Specified Timepoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04576455
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
November 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Giredestrant
Arm Type
Experimental
Arm Title
Physician Choice of Endocrine Monotherapy
Arm Type
Active Comparator
Arm Description
The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Giredestrant
Other Intervention Name(s)
GDC-9545, RO7197597, RG6171
Intervention Description
Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant or an Aromatase Inhibitor (Physician Choice)
Intervention Description
Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.
Intervention Type
Drug
Intervention Name(s)
LHRH Agonist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Description
PFS was defined as the 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.
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to a clinical cutoff of 15 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization to death from any cause (up to approximately 36 months)
Title
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Description
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.
Time Frame
From randomization until disease progression or death (up to approximately 36 months)
Title
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Description
DOR is defined as the 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.
Time Frame
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Title
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Description
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.
Time Frame
From randomization until disease progression or death (up to approximately 36 months)
Title
Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor 1 (ESR1) Mutation Status
Description
PFS was defined as the 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).
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to a clinical cutoff of 15 months)
Title
Time to Deterioration (TTD) in Pain Severity
Description
TTD in pain severity is defined as time to first documented ≥2-point increase from Baseline in the "Worst Pain" item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire. 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.
Time Frame
From Baseline until treatment discontinuation (up to approximately 36 months)
Title
TTD in Pain Presence and Interference, Defined as Time to First Documented ≥10-Point Increase From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Linearly Transformed Pain Scale Score
Description
EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The functioning and symptoms items are scored on a 4-point scale that ranges from 1=not at all to 4=very much. The Pain scale is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate worse pain symptoms.
Time Frame
From Baseline until treatment discontinuation (up to approximately 36 months)
Title
TTD in Physical Functioning (PF)
Description
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. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The PF scale has 5 questions about participants' physical functioning and is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level (better physical function).
Time Frame
From Baseline until treatment discontinuation (up to approximately 36 months)
Title
TTD in Role Functioning (RF)
Description
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. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The RF scale is scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate better functioning/support.
Time Frame
From Baseline until treatment discontinuation (up to approximately 36 months)
Title
TTD in Global Health Status and Quality of Life (GHS/QoL)
Description
TTD in GHS/QoL is defined as the time to first documented ≥10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed GHS/QoL scale score. EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health and quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a better QoL.
Time Frame
From Baseline until treatment discontinuation (up to approximately 36 months)
Title
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)
Description
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.
Time Frame
From Baseline until 30 days after final dose of study drug (up to approximately 36 months)
Title
Number of Participants With Vital Sign Abnormalities Over the Course of the Study
Description
Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.
Time Frame
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 36 months)
Title
Number of Participants With Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study
Description
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).
Time Frame
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 36 months)
Title
Number of Participants With Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study
Description
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).
Time Frame
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 36 months)
Title
Plasma Concentration of Giredestrant at Specified Timepoints
Time Frame
Predose and postdose on Day 1 of Cycles 1 and 2, predose on Day 1 of Cycles 3, 5, 7, 9, 11, 13, and 15 (1 cycle is 28 days), and 30 days after final dose of study drug (up to approximately 36 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101-7016
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Northwest Cancer Specialists - Portland (SW Barnes Rd)
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Texas Oncology - Houston (Gessner)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology- Northeast Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Instituto Angel Roffo
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Fundación Scherbovsky; General Department
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Hosp Provincial D. Centenarios; Oncology Dept
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Kinghorn Cancer Centre; St Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Pronutrir - suporte nutricional e quimioterapia ltda.
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60810-180
Country
Brazil
Facility Name
Hospital de Caridade de Ijui; Oncologia
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Linyishi Cancer Hospital
City
Linyi City
ZIP/Postal Code
276034
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang City
ZIP/Postal Code
330009
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
City
Stralsund
ZIP/Postal Code
18439
Country
Germany
Facility Name
Assuta Medical Center- Ashdod; Oncology
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Hadassah Ein Karem Hospital; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Facility Name
Meir Medical Center; Oncology
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Dongnam-gu, Cheonan-si
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
City
Krasnoyarsk
State/Province
Krasnodar
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Combined Treatment
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
St. Petersburg SHI "City Clinical Oncology Dispensary"
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Clinical Oncology Centre # 1; Chemotherapy Dept
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Multidisciplinary clinic Reaviz
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Petrov Research Inst. of Oncology
City
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Iatros International
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Cancercare Langenhoven Drive Oncology Centre
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Eastleigh Breast Care Centre
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Changhua Christian Hospital; Dept of Surgery
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chi-Mei Medical Centre; Hematology & Oncology
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
Chang Gung Memorial Hosipital at Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
City
Chang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Memorial Antalya Hospital
City
Antalya
ZIP/Postal Code
07025
Country
Turkey
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Facility Name
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Facility Name
Katip Celebi University Ataturk Training and Research Hospital; Oncology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Medikal Park Samsun
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Zhytomyr Regional Oncology Center
City
Zhytomyr
State/Province
KIEV Governorate
ZIP/Postal Code
10007
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
RCI Sumy Regional Clinical Oncological Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Princess Alexandra Hospital; Oncology Department
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Guys & St Thomas Hospital; Department of Oncology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Nottingham City Hospital; Oncology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Peterborough City Hospital; Oncology Research Department 018
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Learn more about this trial
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)
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