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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05654623




Registration number
NCT05654623
Ethics application status
Date submitted
16/11/2022
Date registered
16/12/2022

Titles & IDs
Public title
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
Scientific title
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
Secondary ID [1] 0 0
2022-500544-38-00
Secondary ID [2] 0 0
C4891001
Universal Trial Number (UTN)
Trial acronym
VERITAC-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - ARV-471
Treatment: Drugs - Fulvestrant

Experimental: ARV-471 -

Active comparator: Fulvestrant -


Treatment: Drugs: ARV-471
orally, once daily on a 28-day continuous dosing schedule

Treatment: Drugs: Fulvestrant
intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization date (every 8 weeks for the first 48 weeks and then every 12 weeks thereafter) to date of first documentation of progression OR death (approximately 2 years).
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From randomization date (every 3 months) to date of death (approximately 3 years)
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death (approximately to 2 years).
Secondary outcome [3] 0 0
Duration of response (DR)
Timepoint [3] 0 0
From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) to the date of disease progression or death (approximately to 2 years).
Secondary outcome [4] 0 0
Clinical Benefit Rate
Timepoint [4] 0 0
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
Secondary outcome [5] 0 0
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities
Timepoint [5] 0 0
From screening until 28 days after the last dose (approximately 2 years).
Secondary outcome [6] 0 0
QT Interval (QTc)
Timepoint [6] 0 0
From baseline to end of treatment (approximately 2 years).
Secondary outcome [7] 0 0
Plasma Concentration Versus Time of ARV-471
Timepoint [7] 0 0
From randomization date up to cycle 7 (each cycle is 28 days).
Secondary outcome [8] 0 0
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Timepoint [8] 0 0
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Secondary outcome [9] 0 0
Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Timepoint [9] 0 0
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Secondary outcome [10] 0 0
Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire
Timepoint [10] 0 0
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Secondary outcome [11] 0 0
Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.
Timepoint [11] 0 0
From screening and every cycle until cycle 6 (cycle=28 days) and then every other cycle until 28 days after the last dose (appr. 2 yrs).The modified BPI-SF (worst pain severity and pain interference) daily from baseline until the EOT (appr 2 yrs)
Secondary outcome [12] 0 0
circulating deoxyribonucleic acid (DNA)
Timepoint [12] 0 0
From baseline to end of treatment (approximately 2 years).

Eligibility
Key inclusion criteria
* Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
* Confirmed diagnosis of ER+/HER2- breast cancer
* Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
* One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one line of CDK4/6 inhibitor is allowed in any setting.
* = 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
* Most recent endocrine treatment duration must have been given for =6 months prior to disease progression. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy.
* Radiological progression during or after the last line of therapy.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Participants should be willing to provide blood and tumor tissue
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
* Prior treatment with:
* ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
* other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting
* prior chemotherapy for advanced/metastatic disease
* Inadequate liver, kidney and bone marrow function
* Active brain metastases
* Participants with significant concomitant illness

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2028
Actual
Sample size
Target
Accrual to date
Final
624
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
ICON Cancer Centre - Kurralta Park - Kurralta Park
Recruitment hospital [5] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [6] 0 0
Cabrini Hospital -Brighton - Brighton
Recruitment hospital [7] 0 0
Barwon Health - Geelong
Recruitment hospital [8] 0 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3186 - Brighton
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment outside Australia
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Changhua
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Kaohsiung
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Taichung
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Taipei
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Taoyuan
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I?stanbul
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Antalya
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Edirne
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Malatya
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Samsun
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London, CITY OF
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United Kingdom
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Oxfordshire
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United Kingdom
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Blackburn
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Glasgow
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arvinas Estrogen Receptor, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT05654623