Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04546009




Registration number
NCT04546009
Ethics application status
Date submitted
8/09/2020
Date registered
11/09/2020

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Scientific title
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2020-000119-66
Secondary ID [2] 0 0
BO41843
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 - Giredestrant-matched Placebo
Treatment: Drugs - Letrozole
Treatment: Drugs - Letrozole-matched Placebo
Treatment: Drugs - Palbociclib
Treatment: Drugs - LHRH Agonist

Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib -

Active comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib -


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

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

Treatment: Drugs: Letrozole
Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Letrozole-matched Placebo
Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Palbociclib
Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

Treatment: Drugs: LHRH Agonist
Only premenopausal/perimenopausal 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 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 78 months)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization to death from any cause (up to 78 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 78 months)
Secondary outcome [3] 0 0
Duration of Response, 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 78 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 78 months)
Secondary outcome [5] 0 0
Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented =2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire
Timepoint [5] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [6] 0 0
Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented =10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score
Timepoint [6] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [7] 0 0
Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score
Timepoint [7] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [8] 0 0
Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score
Timepoint [8] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [9] 0 0
Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score
Timepoint [9] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [10] 0 0
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Timepoint [10] 0 0
From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)
Secondary outcome [11] 0 0
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Timepoint [11] 0 0
Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)
Secondary outcome [12] 0 0
Plasma Concentration of Giredestrant at Specified Timepoints
Timepoint [12] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)
Secondary outcome [13] 0 0
Plasma Concentration of Palbociclib at Specified Timepoints
Timepoint [13] 0 0
Days 1 and 15 of Cycle 1 (1 cycle is 28 days)

Eligibility
Key inclusion criteria
* For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
* No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
* Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
* 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 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
* Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
* Prior treatment with a selective estrogen receptor degrader (SERD)
* Treatment with any investigational therapy within 28 days prior to study treatment
* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
9/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/03/2028
Actual
Sample size
Target
Accrual to date
Final
992
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre; Medical Oncology - Bedford Park
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-East Melbourne - Melbourne
Recruitment hospital [6] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Medical Oncology - Murdoch
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Ciudad Autonoma Bs As
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autonoma Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Argentina
State/province [23] 0 0
Vicente López
Country [24] 0 0
Austria
State/province [24] 0 0
Salzburg
Country [25] 0 0
Austria
State/province [25] 0 0
Steyr
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Hasselt
Country [29] 0 0
Brazil
State/province [29] 0 0
BA
Country [30] 0 0
Brazil
State/province [30] 0 0
GO
Country [31] 0 0
Brazil
State/province [31] 0 0
PE
Country [32] 0 0
Brazil
State/province [32] 0 0
RS
Country [33] 0 0
Brazil
State/province [33] 0 0
SP
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
China
State/province [38] 0 0
Anyang City
Country [39] 0 0
China
State/province [39] 0 0
Baoding
Country [40] 0 0
China
State/province [40] 0 0
Beijing
Country [41] 0 0
China
State/province [41] 0 0
Bengbu City
Country [42] 0 0
China
State/province [42] 0 0
Changchun City
Country [43] 0 0
China
State/province [43] 0 0
Changsha CITY
Country [44] 0 0
China
State/province [44] 0 0
Fuzhou City
Country [45] 0 0
China
State/province [45] 0 0
Guangzhou City
Country [46] 0 0
China
State/province [46] 0 0
Guangzhou
Country [47] 0 0
China
State/province [47] 0 0
Hangzhou City
Country [48] 0 0
China
State/province [48] 0 0
Harbin
Country [49] 0 0
China
State/province [49] 0 0
Jinan
Country [50] 0 0
China
State/province [50] 0 0
Nanchang City
Country [51] 0 0
China
State/province [51] 0 0
Nanjing City
Country [52] 0 0
China
State/province [52] 0 0
Nanning City
Country [53] 0 0
China
State/province [53] 0 0
Shantou
Country [54] 0 0
China
State/province [54] 0 0
ShenYang
Country [55] 0 0
China
State/province [55] 0 0
Shenyang
Country [56] 0 0
China
State/province [56] 0 0
Wuhan City
Country [57] 0 0
China
State/province [57] 0 0
Wuhan
Country [58] 0 0
China
State/province [58] 0 0
Xi'an City
Country [59] 0 0
Denmark
State/province [59] 0 0
Herlev
Country [60] 0 0
Denmark
State/province [60] 0 0
Naestved
Country [61] 0 0
Denmark
State/province [61] 0 0
Odense C
Country [62] 0 0
France
State/province [62] 0 0
Angers
Country [63] 0 0
France
State/province [63] 0 0
Bayonne
Country [64] 0 0
France
State/province [64] 0 0
La Roche Sur Yon
Country [65] 0 0
France
State/province [65] 0 0
Montpellier
Country [66] 0 0
France
State/province [66] 0 0
Poitiers
Country [67] 0 0
France
State/province [67] 0 0
Reims CEDEX
Country [68] 0 0
France
State/province [68] 0 0
Rennes
Country [69] 0 0
France
State/province [69] 0 0
Saint-Priest en Jarez
Country [70] 0 0
France
State/province [70] 0 0
Vandoeuvre-les-nancy
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Chemnitz
Country [73] 0 0
Germany
State/province [73] 0 0
Dresden
Country [74] 0 0
Germany
State/province [74] 0 0
Essen
Country [75] 0 0
Germany
State/province [75] 0 0
Georgsmarienhütte
Country [76] 0 0
Germany
State/province [76] 0 0
Göttingen
Country [77] 0 0
Germany
State/province [77] 0 0
Hamburg
Country [78] 0 0
Germany
State/province [78] 0 0
Hannover
Country [79] 0 0
Germany
State/province [79] 0 0
Heidelberg
Country [80] 0 0
Germany
State/province [80] 0 0
Koblenz
Country [81] 0 0
Germany
State/province [81] 0 0
Langen
Country [82] 0 0
Germany
State/province [82] 0 0
Leipzig
Country [83] 0 0
Germany
State/province [83] 0 0
Mannheim
Country [84] 0 0
Germany
State/province [84] 0 0
München
Country [85] 0 0
Germany
State/province [85] 0 0
Ravensburg
Country [86] 0 0
Germany
State/province [86] 0 0
Trier
Country [87] 0 0
Germany
State/province [87] 0 0
Troisdorf
Country [88] 0 0
Germany
State/province [88] 0 0
Tübingen
Country [89] 0 0
Greece
State/province [89] 0 0
Athens
Country [90] 0 0
Greece
State/province [90] 0 0
Larissa
Country [91] 0 0
Greece
State/province [91] 0 0
Thessaloniki
Country [92] 0 0
Hong Kong
State/province [92] 0 0
Hong Kong
Country [93] 0 0
Hungary
State/province [93] 0 0
Budapest
Country [94] 0 0
Israel
State/province [94] 0 0
Petah Tiqwa
Country [95] 0 0
Israel
State/province [95] 0 0
Ramat Gan
Country [96] 0 0
Israel
State/province [96] 0 0
Tel Aviv
Country [97] 0 0
Italy
State/province [97] 0 0
Emilia-Romagna
Country [98] 0 0
Italy
State/province [98] 0 0
Lazio
Country [99] 0 0
Italy
State/province [99] 0 0
Lombardia
Country [100] 0 0
Italy
State/province [100] 0 0
Piemonte
Country [101] 0 0
Italy
State/province [101] 0 0
Sicilia
Country [102] 0 0
Italy
State/province [102] 0 0
Toscana
Country [103] 0 0
Italy
State/province [103] 0 0
Veneto
Country [104] 0 0
Japan
State/province [104] 0 0
Aichi
Country [105] 0 0
Japan
State/province [105] 0 0
Chiba
Country [106] 0 0
Japan
State/province [106] 0 0
Fukuoka
Country [107] 0 0
Japan
State/province [107] 0 0
Hiroshima
Country [108] 0 0
Japan
State/province [108] 0 0
Hokkaido
Country [109] 0 0
Japan
State/province [109] 0 0
Hyogo
Country [110] 0 0
Japan
State/province [110] 0 0
Ibaraki
Country [111] 0 0
Japan
State/province [111] 0 0
Kagoshima
Country [112] 0 0
Japan
State/province [112] 0 0
Kanagawa
Country [113] 0 0
Japan
State/province [113] 0 0
Kumamoto
Country [114] 0 0
Japan
State/province [114] 0 0
Miyagi
Country [115] 0 0
Japan
State/province [115] 0 0
Niigata
Country [116] 0 0
Japan
State/province [116] 0 0
Okinawa
Country [117] 0 0
Japan
State/province [117] 0 0
Osaka
Country [118] 0 0
Japan
State/province [118] 0 0
Saitama
Country [119] 0 0
Japan
State/province [119] 0 0
Tokyo
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Cheongju-si
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Daegu
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Goyang-si
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Incheon
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seongnam-si
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Ulsan
Country [127] 0 0
Mexico
State/province [127] 0 0
Jalisco
Country [128] 0 0
Mexico
State/province [128] 0 0
Mexico CITY (federal District)
Country [129] 0 0
Mexico
State/province [129] 0 0
Nuevo LEON
Country [130] 0 0
Mexico
State/province [130] 0 0
Oaxaca
Country [131] 0 0
Mexico
State/province [131] 0 0
SAN LUIS Potosi
Country [132] 0 0
Mexico
State/province [132] 0 0
Veracruz
Country [133] 0 0
New Zealand
State/province [133] 0 0
Auckland
Country [134] 0 0
Peru
State/province [134] 0 0
Lima
Country [135] 0 0
Peru
State/province [135] 0 0
San Isidro
Country [136] 0 0
Peru
State/province [136] 0 0
Trujillo
Country [137] 0 0
Poland
State/province [137] 0 0
Gdansk
Country [138] 0 0
Poland
State/province [138] 0 0
Gdynia
Country [139] 0 0
Poland
State/province [139] 0 0
Warszawa
Country [140] 0 0
Portugal
State/province [140] 0 0
Coimbra
Country [141] 0 0
Portugal
State/province [141] 0 0
Lisboa
Country [142] 0 0
Portugal
State/province [142] 0 0
Porto
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Mordovija
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Moskovskaja Oblast
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Rjazan
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Sankt Petersburg
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Chelyabinsk
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Samara
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Yaroslavl
Country [150] 0 0
Spain
State/province [150] 0 0
Barcelona
Country [151] 0 0
Spain
State/province [151] 0 0
Guipuzcoa
Country [152] 0 0
Spain
State/province [152] 0 0
LA Coruña
Country [153] 0 0
Spain
State/province [153] 0 0
Madrid
Country [154] 0 0
Spain
State/province [154] 0 0
Lugo
Country [155] 0 0
Spain
State/province [155] 0 0
Sevilla
Country [156] 0 0
Spain
State/province [156] 0 0
Valencia
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taichung
Country [158] 0 0
Taiwan
State/province [158] 0 0
Tainan
Country [159] 0 0
Taiwan
State/province [159] 0 0
Taipei
Country [160] 0 0
Taiwan
State/province [160] 0 0
Taoyuan City
Country [161] 0 0
Thailand
State/province [161] 0 0
Bangkok
Country [162] 0 0
Thailand
State/province [162] 0 0
Chang Mai
Country [163] 0 0
Thailand
State/province [163] 0 0
Songkhla
Country [164] 0 0
Turkey
State/province [164] 0 0
Ankara
Country [165] 0 0
Turkey
State/province [165] 0 0
Edirne
Country [166] 0 0
Turkey
State/province [166] 0 0
Istanbul
Country [167] 0 0
Turkey
State/province [167] 0 0
Izmir
Country [168] 0 0
Turkey
State/province [168] 0 0
Izmit
Country [169] 0 0
Turkey
State/province [169] 0 0
Kadiköy
Country [170] 0 0
Turkey
State/province [170] 0 0
Kepez
Country [171] 0 0
Turkey
State/province [171] 0 0
Malatya
Country [172] 0 0
Turkey
State/province [172] 0 0
Samsun
Country [173] 0 0
Turkey
State/province [173] 0 0
Sihhiye/Ankara
Country [174] 0 0
Ukraine
State/province [174] 0 0
Katerynoslav Governorate
Country [175] 0 0
Ukraine
State/province [175] 0 0
Kharkiv Governorate
Country [176] 0 0
Ukraine
State/province [176] 0 0
Ivano-Frankivsk
Country [177] 0 0
Ukraine
State/province [177] 0 0
Kryvyi Rih
Country [178] 0 0
Ukraine
State/province [178] 0 0
Sumy
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Brighton
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Leicester
Country [181] 0 0
United Kingdom
State/province [181] 0 0
London
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Maidstone
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Peterborough
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Plymouth
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Sutton
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Truro

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?
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
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04546009