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/NCT06065748




Registration number
NCT06065748
Ethics application status
Date submitted
26/09/2023
Date registered
4/10/2023

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Scientific title
A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Secondary ID [1] 0 0
2022-502980-39-00
Secondary ID [2] 0 0
CO44657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Estrogen Receptor-Positive, HER2-Negative Advanced 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
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Ribociclib
Treatment: Drugs - LHRH Agonist
Diagnosis / Prognosis - FoundationOne Liquid CDx Assay (F1LCDx)

Experimental: Giredestrant + Investigator's Choice of CDK4/6i - Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Active comparator: Fulvestrant + Investigator's Choice of CDK4/6i - Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.


Treatment: Drugs: Giredestrant
Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Abemaciclib
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Palbociclib
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Ribociclib
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: LHRH Agonist
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

Diagnosis / Prognosis: FoundationOne Liquid CDx Assay (F1LCDx)
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup
Timepoint [1] 0 0
From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
Primary outcome [2] 0 0
PFS in the Full Analysis Set (FAS) Population
Timepoint [2] 0 0
From randomization to first occurrence of PD or death (up to 5 years)
Secondary outcome [1] 0 0
PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup
Timepoint [1] 0 0
From randomization to first occurrence of PD or death (up to 5 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization until death from any cause (up to 5 years)
Secondary outcome [3] 0 0
Confirmed Objective Response Rate (cORR)
Timepoint [3] 0 0
From randomization until treatment discontinuation (up to 5 years)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
From the first occurrence of a documented objective response to PD or death (up to 5 years)
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
From randomization until treatment discontinuation (up to 5 years)
Secondary outcome [6] 0 0
Time to Chemotherapy
Timepoint [6] 0 0
From randomization until the start of chemotherapy or death (up to 5 years)
Secondary outcome [7] 0 0
Time to Confirmed Deterioration (TTCD) in Pain Severity
Timepoint [7] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [8] 0 0
TTCD in Pain Presence and Interference
Timepoint [8] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [9] 0 0
TTCD in Physical Functioning
Timepoint [9] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [10] 0 0
TTCD in Role Functioning
Timepoint [10] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [11] 0 0
TTCD in Global Health Status/Quality of Life
Timepoint [11] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [12] 0 0
Incidence and Severity of Adverse Events
Timepoint [12] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [13] 0 0
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Timepoint [13] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [14] 0 0
Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study
Timepoint [14] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)

Eligibility
Key inclusion criteria
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2028
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [2] 0 0
Nepean Hospital; Nepean Cancer Care Centre - Kingswood
Recruitment hospital [3] 0 0
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research - North Sydney
Recruitment hospital [4] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [5] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment hospital [6] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [7] 0 0
Barwon Health - Geelong
Recruitment hospital [8] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [9] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment postcode(s) [9] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autonoma Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Argentina
State/province [23] 0 0
La Rioja
Country [24] 0 0
Argentina
State/province [24] 0 0
Recoleta
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
San Juan
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Linz
Country [29] 0 0
Austria
State/province [29] 0 0
Steyr
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
Country [31] 0 0
Belgium
State/province [31] 0 0
Gent
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Liège
Country [34] 0 0
Belgium
State/province [34] 0 0
Namur
Country [35] 0 0
Belgium
State/province [35] 0 0
Wilrijk
Country [36] 0 0
Brazil
State/province [36] 0 0
BA
Country [37] 0 0
Brazil
State/province [37] 0 0
CE
Country [38] 0 0
Brazil
State/province [38] 0 0
ES
Country [39] 0 0
Brazil
State/province [39] 0 0
GO
Country [40] 0 0
Brazil
State/province [40] 0 0
MA
Country [41] 0 0
Brazil
State/province [41] 0 0
PE
Country [42] 0 0
Brazil
State/province [42] 0 0
RJ
Country [43] 0 0
Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
SP
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Canada
State/province [47] 0 0
Saskatchewan
Country [48] 0 0
Chile
State/province [48] 0 0
Puerto Montt
Country [49] 0 0
Chile
State/province [49] 0 0
Santiago
Country [50] 0 0
China
State/province [50] 0 0
Beijing
Country [51] 0 0
China
State/province [51] 0 0
Changchun City
Country [52] 0 0
China
State/province [52] 0 0
Changsha CITY
Country [53] 0 0
China
State/province [53] 0 0
Chengdu City
Country [54] 0 0
China
State/province [54] 0 0
Chengdu
Country [55] 0 0
China
State/province [55] 0 0
Chongqing
Country [56] 0 0
China
State/province [56] 0 0
Fuzhou City
Country [57] 0 0
China
State/province [57] 0 0
Guangzhou City
Country [58] 0 0
China
State/province [58] 0 0
Hangzhou
Country [59] 0 0
China
State/province [59] 0 0
Harbin
Country [60] 0 0
China
State/province [60] 0 0
Jinan City
Country [61] 0 0
China
State/province [61] 0 0
Jinan
Country [62] 0 0
China
State/province [62] 0 0
Kunming City
Country [63] 0 0
China
State/province [63] 0 0
Luoyang City
Country [64] 0 0
China
State/province [64] 0 0
Nanning City
Country [65] 0 0
China
State/province [65] 0 0
Shanghai City
Country [66] 0 0
China
State/province [66] 0 0
Shanghai
Country [67] 0 0
China
State/province [67] 0 0
Taiyuan City
Country [68] 0 0
China
State/province [68] 0 0
Taizhou
Country [69] 0 0
China
State/province [69] 0 0
Tianjin
Country [70] 0 0
China
State/province [70] 0 0
Urumqi
Country [71] 0 0
China
State/province [71] 0 0
Wuhan City
Country [72] 0 0
China
State/province [72] 0 0
Wuhan
Country [73] 0 0
China
State/province [73] 0 0
Xi'an City
Country [74] 0 0
China
State/province [74] 0 0
Xian
Country [75] 0 0
China
State/province [75] 0 0
Xuzhou
Country [76] 0 0
China
State/province [76] 0 0
Zhejiang
Country [77] 0 0
China
State/province [77] 0 0
Zhengzhou
Country [78] 0 0
Colombia
State/province [78] 0 0
Bogota, D.C.
Country [79] 0 0
Colombia
State/province [79] 0 0
Cali
Country [80] 0 0
Colombia
State/province [80] 0 0
Monteria
Country [81] 0 0
Colombia
State/province [81] 0 0
Valledupar
Country [82] 0 0
Costa Rica
State/province [82] 0 0
San José
Country [83] 0 0
Finland
State/province [83] 0 0
Kuopio
Country [84] 0 0
Finland
State/province [84] 0 0
Tampere
Country [85] 0 0
France
State/province [85] 0 0
Avignon
Country [86] 0 0
France
State/province [86] 0 0
Besancon
Country [87] 0 0
France
State/province [87] 0 0
Caen
Country [88] 0 0
France
State/province [88] 0 0
La Rochelle
Country [89] 0 0
France
State/province [89] 0 0
Lille
Country [90] 0 0
France
State/province [90] 0 0
Lyon
Country [91] 0 0
France
State/province [91] 0 0
Montpellier
Country [92] 0 0
France
State/province [92] 0 0
Reims CEDEX
Country [93] 0 0
France
State/province [93] 0 0
Rennes
Country [94] 0 0
France
State/province [94] 0 0
Toulouse
Country [95] 0 0
France
State/province [95] 0 0
Villejuif
Country [96] 0 0
Germany
State/province [96] 0 0
Deggendorf
Country [97] 0 0
Germany
State/province [97] 0 0
Düsseldorf
Country [98] 0 0
Germany
State/province [98] 0 0
Essen
Country [99] 0 0
Germany
State/province [99] 0 0
Freiburg
Country [100] 0 0
Germany
State/province [100] 0 0
Heidelberg
Country [101] 0 0
Germany
State/province [101] 0 0
Homburg/Saar
Country [102] 0 0
Germany
State/province [102] 0 0
Koeln
Country [103] 0 0
Germany
State/province [103] 0 0
Muenchen
Country [104] 0 0
Germany
State/province [104] 0 0
Mönchengladbach
Country [105] 0 0
Guatemala
State/province [105] 0 0
Ciudad de Guatemala
Country [106] 0 0
Guatemala
State/province [106] 0 0
Guatemala City
Country [107] 0 0
Guatemala
State/province [107] 0 0
Guatemala
Country [108] 0 0
Guatemala
State/province [108] 0 0
Quetzaltenango
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Hong Kong
Country [110] 0 0
Hungary
State/province [110] 0 0
Kecskemét
Country [111] 0 0
Hungary
State/province [111] 0 0
Miskolc
Country [112] 0 0
Hungary
State/province [112] 0 0
Salgótarján
Country [113] 0 0
India
State/province [113] 0 0
Delhi
Country [114] 0 0
India
State/province [114] 0 0
Kerala
Country [115] 0 0
India
State/province [115] 0 0
Maharashtra
Country [116] 0 0
Israel
State/province [116] 0 0
Jerusalem
Country [117] 0 0
Israel
State/province [117] 0 0
Petah Tikva
Country [118] 0 0
Israel
State/province [118] 0 0
Ramat Gan
Country [119] 0 0
Israel
State/province [119] 0 0
Tel-Aviv
Country [120] 0 0
Italy
State/province [120] 0 0
Campania
Country [121] 0 0
Italy
State/province [121] 0 0
Emilia-Romagna
Country [122] 0 0
Italy
State/province [122] 0 0
Friuli-Venezia Giulia
Country [123] 0 0
Italy
State/province [123] 0 0
Lazio
Country [124] 0 0
Italy
State/province [124] 0 0
Lombardia
Country [125] 0 0
Italy
State/province [125] 0 0
Marche
Country [126] 0 0
Italy
State/province [126] 0 0
Piemonte
Country [127] 0 0
Italy
State/province [127] 0 0
Puglia
Country [128] 0 0
Italy
State/province [128] 0 0
Sicilia
Country [129] 0 0
Italy
State/province [129] 0 0
Toscana
Country [130] 0 0
Italy
State/province [130] 0 0
Veneto
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Daegu
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Seongnam-si
Country [133] 0 0
Korea, Republic of
State/province [133] 0 0
Seoul
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Ulsan
Country [135] 0 0
Mexico
State/province [135] 0 0
Jalisco
Country [136] 0 0
Mexico
State/province [136] 0 0
Mexico CITY (federal District)
Country [137] 0 0
Mexico
State/province [137] 0 0
Oaxaca
Country [138] 0 0
Mexico
State/province [138] 0 0
Queretaro
Country [139] 0 0
Mexico
State/province [139] 0 0
Mexico City
Country [140] 0 0
New Zealand
State/province [140] 0 0
Palmerston North
Country [141] 0 0
Poland
State/province [141] 0 0
?ód?
Country [142] 0 0
Poland
State/province [142] 0 0
Bydgoszcz
Country [143] 0 0
Poland
State/province [143] 0 0
Gdynia
Country [144] 0 0
Poland
State/province [144] 0 0
Gliwice
Country [145] 0 0
Poland
State/province [145] 0 0
Kielce
Country [146] 0 0
Poland
State/province [146] 0 0
Konin
Country [147] 0 0
Poland
State/province [147] 0 0
Koszalin
Country [148] 0 0
Poland
State/province [148] 0 0
Lublin
Country [149] 0 0
Poland
State/province [149] 0 0
Siedlce
Country [150] 0 0
Poland
State/province [150] 0 0
Szczecin
Country [151] 0 0
Poland
State/province [151] 0 0
Warszawa
Country [152] 0 0
Portugal
State/province [152] 0 0
Coimbra
Country [153] 0 0
Portugal
State/province [153] 0 0
Lisboa
Country [154] 0 0
Portugal
State/province [154] 0 0
Porto
Country [155] 0 0
Portugal
State/province [155] 0 0
Vila Nova de Gaia
Country [156] 0 0
Singapore
State/province [156] 0 0
Singapore
Country [157] 0 0
Slovenia
State/province [157] 0 0
Ljubljana
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Cadiz
Country [160] 0 0
Spain
State/province [160] 0 0
Madrid
Country [161] 0 0
Spain
State/province [161] 0 0
Murcia
Country [162] 0 0
Spain
State/province [162] 0 0
Pontevedra
Country [163] 0 0
Spain
State/province [163] 0 0
Huelva
Country [164] 0 0
Spain
State/province [164] 0 0
Jaen
Country [165] 0 0
Spain
State/province [165] 0 0
Sevilla
Country [166] 0 0
Spain
State/province [166] 0 0
Valencia
Country [167] 0 0
Taiwan
State/province [167] 0 0
Hsinchu City
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taipei City
Country [170] 0 0
Taiwan
State/province [170] 0 0
Taipei
Country [171] 0 0
Taiwan
State/province [171] 0 0
Xitun Dist.
Country [172] 0 0
Thailand
State/province [172] 0 0
Bangkok
Country [173] 0 0
Thailand
State/province [173] 0 0
Lak Si
Country [174] 0 0
Thailand
State/province [174] 0 0
Muang Chiang MAI Delivery Branch 3
Country [175] 0 0
Thailand
State/province [175] 0 0
Songkhla

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
Reference Study ID Number: CO44657 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
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/NCT06065748