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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04576455




Registration number
NCT04576455
Ethics application status
Date submitted
30/09/2020
Date registered
6/10/2020

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2020-001984-10
Secondary ID [2] 0 0
WO42312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Giredestrant
Treatment: Drugs - Fulvestrant or an Aromatase Inhibitor (Physician Choice)
Treatment: Drugs - LHRH Agonist

Experimental: Giredestrant -

Active comparator: Physician Choice of Endocrine Monotherapy - The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.


Treatment: Drugs: Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
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 [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death from any cause (up to approximately 36 months)
Secondary outcome [2] 0 0
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Timepoint [2] 0 0
From randomization until disease progression or death (up to approximately 36 months)
Secondary outcome [3] 0 0
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Timepoint [3] 0 0
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [4] 0 0
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Timepoint [4] 0 0
From randomization until disease progression or death (up to approximately 36 months)
Secondary outcome [5] 0 0
Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor 1 (ESR1) Mutation Status
Timepoint [5] 0 0
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 [6] 0 0
Time to Deterioration (TTD) in Pain Severity
Timepoint [6] 0 0
From Baseline until treatment discontinuation (up to approximately 36 months)
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
From Baseline until treatment discontinuation (up to approximately 36 months)
Secondary outcome [8] 0 0
TTD in Physical Functioning (PF)
Timepoint [8] 0 0
From Baseline until treatment discontinuation (up to approximately 36 months)
Secondary outcome [9] 0 0
TTD in Role Functioning (RF)
Timepoint [9] 0 0
From Baseline until treatment discontinuation (up to approximately 36 months)
Secondary outcome [10] 0 0
TTD in Global Health Status and Quality of Life (GHS/QoL)
Timepoint [10] 0 0
From Baseline until treatment discontinuation (up to approximately 36 months)
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
From Baseline until 30 days after final dose of study drug (up to approximately 36 months)
Secondary outcome [12] 0 0
Number of Participants With Vital Sign Abnormalities Over the Course of the Study
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Number of Participants With Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Number of Participants With Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Plasma Concentration of Giredestrant at Specified Timepoints
Timepoint [15] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Montana
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autonoma Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Mendoza
Country [11] 0 0
Argentina
State/province [11] 0 0
Rosario
Country [12] 0 0
Argentina
State/province [12] 0 0
San Nicolás
Country [13] 0 0
Brazil
State/province [13] 0 0
CE
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Brazil
State/province [15] 0 0
SP
Country [16] 0 0
China
State/province [16] 0 0
Changchun City
Country [17] 0 0
China
State/province [17] 0 0
Guangzhou City
Country [18] 0 0
China
State/province [18] 0 0
Harbin
Country [19] 0 0
China
State/province [19] 0 0
Linyi City
Country [20] 0 0
China
State/province [20] 0 0
Nanchang City
Country [21] 0 0
China
State/province [21] 0 0
Shanghai City
Country [22] 0 0
China
State/province [22] 0 0
Tianjin
Country [23] 0 0
China
State/province [23] 0 0
Wuhan
Country [24] 0 0
China
State/province [24] 0 0
Xi'an
Country [25] 0 0
China
State/province [25] 0 0
Zhejiang
Country [26] 0 0
Germany
State/province [26] 0 0
Aschaffenburg
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Paderborn
Country [30] 0 0
Germany
State/province [30] 0 0
Stralsund
Country [31] 0 0
Israel
State/province [31] 0 0
Ashdod
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Israel
State/province [33] 0 0
Kfar-Saba
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Dongnam-gu, Cheonan-si
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Goyang-si
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Poland
State/province [37] 0 0
Bialystok
Country [38] 0 0
Poland
State/province [38] 0 0
Gliwice
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Krasnodar
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moskovskaja Oblast
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Niznij Novgorod
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Sankt Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Tatarstan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Samara
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Volgograd
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Yaroslavl
Country [48] 0 0
Singapore
State/province [48] 0 0
Singapore
Country [49] 0 0
South Africa
State/province [49] 0 0
Bloemfontein
Country [50] 0 0
South Africa
State/province [50] 0 0
Port Elizabeth
Country [51] 0 0
South Africa
State/province [51] 0 0
Pretoria
Country [52] 0 0
Taiwan
State/province [52] 0 0
Changhua
Country [53] 0 0
Taiwan
State/province [53] 0 0
Tainan
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taipei
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taoyuan City
Country [56] 0 0
Thailand
State/province [56] 0 0
Bangkok
Country [57] 0 0
Thailand
State/province [57] 0 0
Chang Mai
Country [58] 0 0
Thailand
State/province [58] 0 0
Songkhla
Country [59] 0 0
Turkey
State/province [59] 0 0
Ankara
Country [60] 0 0
Turkey
State/province [60] 0 0
Antalya
Country [61] 0 0
Turkey
State/province [61] 0 0
Diyarbakir
Country [62] 0 0
Turkey
State/province [62] 0 0
Istanbul
Country [63] 0 0
Turkey
State/province [63] 0 0
Izmir
Country [64] 0 0
Turkey
State/province [64] 0 0
Samsun
Country [65] 0 0
Ukraine
State/province [65] 0 0
KIEV Governorate
Country [66] 0 0
Ukraine
State/province [66] 0 0
Kyiv
Country [67] 0 0
Ukraine
State/province [67] 0 0
Sumy
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Harlow
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Nottingham
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Peterborough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04576455