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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05894239




Registration number
NCT05894239
Ethics application status
Date submitted
24/05/2023
Date registered
8/06/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2022-502046-28-00
Secondary ID [2] 0 0
WO44263
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Inavolisib
Treatment: Drugs - Phesgo
Treatment: Drugs - Placebo
Treatment: Drugs - Taxane-based Chemotherapy
Treatment: Drugs - Optional Endocrine Therapy of Investigator's Choice

Other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy - Participants will be administered the treatments as outlined in the interventions section.

Experimental: Maintenance Therapy: Inavolisib plus Phesgo - Participants will be administered the treatments as outlined in the interventions section.

Active comparator: Maintenance Therapy: Placebo plus Phesgo - Participants will be administered the treatments as outlined in the interventions section.


Treatment: Drugs: Inavolisib
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.

Treatment: Drugs: Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

Treatment: Drugs: Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.

Treatment: Drugs: Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.

Treatment: Drugs: Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Assessed Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 40 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 111 months
Secondary outcome [2] 0 0
Investigator-Assessed Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 111 months
Secondary outcome [3] 0 0
Investigator-Assessed Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 111 months
Secondary outcome [4] 0 0
Investigator-Assessed Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Up to approximately 111 months
Secondary outcome [5] 0 0
Investigator-Assessed PFS2
Timepoint [5] 0 0
Up to approximately 111 months
Secondary outcome [6] 0 0
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Timepoint [6] 0 0
Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days.
Secondary outcome [7] 0 0
Percentage of Participants with Adverse Events
Timepoint [7] 0 0
Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.
Secondary outcome [8] 0 0
Plasma Concentration of Inavolisib at Specified Timepoints
Timepoint [8] 0 0
Day 1 of Cycles 1 and 4. Each cycle is 21 days.

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Adequate hematologic and organ function prior to initiation 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 treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
* History or active inflammatory bowel disease
* Disease progression within 6 months of receiving any HER2-targeted therapy
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Participants with active HBV infection
* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
* Symptomatic active lung disease, including pneumonitis or interstitial lung disease
* Any history of leptomeningeal disease or carcinomatous meningitis
* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2028
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Gosford Hospital; Cancer Care Services - Gosford
Recruitment hospital [4] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital; Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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District of Columbia
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United States of America
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Maryland
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Massachusetts
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Michigan
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New Jersey
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North Carolina
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Oklahoma
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Rosario
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Argentina
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San Juan
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Hasselt
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Belgium
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Namur
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Brazil
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BA
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Brazil
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CE
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Brazil
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GO
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PE
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PR
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RS
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Alberta
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New Brunswick
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Newfoundland and Labrador
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Quebec
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Saskatchewan
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China
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Baoding
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China
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Beijing
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China
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Changchun City
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China
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Chengdu
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China
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Fuzhou
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China
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Hangzhou City
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China
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Harbin
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China
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Jinan
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China
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Luoyang City
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China
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Nanchang
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China
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Nanning City
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China
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Shantou City
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China
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Tianjin
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China
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Wuhan City
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China
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Wuhan
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Colombia
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Barranquilla
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Colombia
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Bogota, D.C.
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Colombia
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Monteria
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Finland
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Tampere
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Turku
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Avignon
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Bordeaux
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Amberg
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Bottrop
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Düsseldorf
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Germany
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Erfurt
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Freiburg
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Germany
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München
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Saarbruecken
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Stralsund
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Lazio
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Piemonte
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Jalisco
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Singapore
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Hilton
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Polokwane
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South Africa
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Pretoria
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Soweto
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Spain
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LA Coruña
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Barcelona
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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Turkey
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Ankara
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Turkey
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Bakirkoy / Istanbul
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Seyhan
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Turkey
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Sihhiye/Ankara
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United Kingdom
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Blackpool
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United Kingdom
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Colchester, Essex
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United Kingdom
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Northwood
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United Kingdom
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Nottingham
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United Kingdom
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Oxford

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: WO44263 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/NCT05894239