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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05909397
Registration number
NCT05909397
Ethics application status
Date submitted
25/05/2023
Date registered
18/06/2023
Titles & IDs
Public title
A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer
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Scientific title
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)
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Secondary ID [1]
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2022-500545-24-00
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Secondary ID [2]
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C4891002
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Universal Trial Number (UTN)
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Trial acronym
VERITAC-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ARV-471 (PF-07850327)
Other interventions - Palbociclib
Treatment: Drugs - Letrozole
Other interventions - Palbociclib
Experimental: Arm A (Investigational Arm) - Participants will receive:
* ARV-471, orally, once daily, continuously, in a 28-day cycle, plus
* Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment in a 28 day cycle
Active comparator: Arm B (Comparator Arm): - Participants will receive:
* Letrozole, orally, once daily, continuously, in a 28-day cycle, plus
* Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle.
Treatment: Drugs: ARV-471 (PF-07850327)
Pharmaceutical form: Tablets. Route of Administration: Oral
Other interventions: Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
Treatment: Drugs: Letrozole
Pharmaceutical form: Capsules. Route of Administration: Orally
Other interventions: Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Study Lead-in (SLI): Incidence of Grade 4 neutropenia
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Assessment method [1]
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It is defined as the number of participants with Grade 4 neutropenia AE (graded by NCI CTCAE v.5.0) with onset within the first 4 cycles divided by the number of participants.
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Timepoint [1]
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From randomization date up to Cycle 4 (each cycle is 28 days).
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Primary outcome [2]
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SLI: Incidence of dose reduction
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Assessment method [2]
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It is defined as the number of participants reducing the dose of palbociclib and/or ARV-471 due to any cause occurring within the first 4 cycles divided by the number of participants.
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Timepoint [2]
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From randomization date up to Cycle 4 (each cycle is 28 days).
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Primary outcome [3]
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SLI: Incidence of drug discontinuation.
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Assessment method [3]
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It is defined as the number of participants discontinuing palbociclib and/or ARV-471 due to any cause occurring within the first 4 cycles divided by the number of participants.
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Timepoint [3]
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From randomization date up to Cycle 4 (each cycle is 28 days).
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Primary outcome [4]
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Phase 3: Progression-Free Survival
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Assessment method [4]
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Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) or death due to any cause, whichever come first.
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Timepoint [4]
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From randomization date, every 12 weeks, to date of first documentation of progression or death, up to approximately 4 years.
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Secondary outcome [1]
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SLI and Phase 3. Objective Response Rate
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Assessment method [1]
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Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1, from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
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Timepoint [1]
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From randomization date, every 12 weeks, to the date of progression or death (up to approximately 4 years).
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Secondary outcome [2]
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SLI and Phase 3: Duration of Response
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Assessment method [2]
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Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1 or death due to any cause, whichever occurs first.
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Timepoint [2]
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From the date of the first objective response, every 12 weeks, to the date of disease progression or death (up to approximately 4 years).
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Secondary outcome [3]
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SLI and Phase 3: Clinical Benefit Rate
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Assessment method [3]
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Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time or SD or non CR/non PD for at least 24 weeks determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1, from the date of randomization until disease progression or death due to any cause, whichever occurs first.
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Timepoint [3]
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Every 12 weeks From randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).
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Secondary outcome [4]
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Phase 3: Overall Survival
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Assessment method [4]
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Overall survival is defined as the time interval from the date of randomization to the date of documented death, due to any cause.
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Timepoint [4]
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From randomization date, every 3 months, to date of death (up to approximately 6 years)
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Secondary outcome [5]
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SLI and Phase 3: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [5]
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It is defined as the number of participants with TEAEs and SAEs divided by the number of participants. AEs and SAEs will be graded according to NCI CTCAE V5.0.
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Timepoint [5]
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From baseline to date to end of treatment (up to approximately 4 years)
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Secondary outcome [6]
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SLI and Phase 3: Incidence of laboratory abnormalities
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Assessment method [6]
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It is defined as the number of participants with laboratory abnormalities divided by the number of participants. Laboratory abnormalities will be graded according to NCI CTCAE V5.0.
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Timepoint [6]
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From baseline to end of treatment (up to approximately 4 years)
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Secondary outcome [7]
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SLI and Phase 3: Incidence of Electrocardiogram (ECG) Abnormalities
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Assessment method [7]
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It is defined as the number of participants with ECG abnormalities divided by the number of participants. ECG abnormalities will be graded according to NCI CTCAE V5.0.
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Timepoint [7]
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From baseline up to the end of treatment (up to approximately 4 years)
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Secondary outcome [8]
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SLI and Phase 3: Plasma concentrations of ARV-471 and palbociclib
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Assessment method [8]
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Plasma concentrations of ARV-471 and palbociclib
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Timepoint [8]
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From randomization date up to Cycle 5 (each cycle is 28 days)
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Secondary outcome [9]
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Phase 3: 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)
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Assessment method [9]
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Change from baseline between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.
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Timepoint [9]
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From baseline, each cycle up to cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days
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Secondary outcome [10]
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Phase 3: 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)
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Assessment method [10]
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Change from baseline between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.
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Timepoint [10]
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From baseline, each cycle up to Cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days.
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Secondary outcome [11]
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Phase 3: 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.
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Assessment method [11]
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Change from baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.
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Timepoint [11]
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From baseline, each cycle up to Cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days.
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Secondary outcome [12]
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Phase 3: Changes from baseline in plasma ctDNA (Circulating Deoxyribonucleic Acid)
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Assessment method [12]
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Quantitative changes from baseline
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Timepoint [12]
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From baseline to end of treatment (up to approximately 4 years)
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Eligibility
Key inclusion criteria
* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
* Confirmed diagnosis of ER+/HER2- breast cancer
* No prior systemic treatment for loco-regional recurrent or metastatic disease
* 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 0-2
* Phase 3 only: Participants should be willing to provide blood and tumor tissue
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Disease recurrence while on, or within 12 months of completion of adjuvant endocrine therapy
* Prior treatment with cyclin dependent kinase 4/6 inhibitors (CDK4/6i), fulvestrant, elacestrant and other investigational drugs including novel endocrine therapies, any selective estrogen receptor degraders (SERDs), covalent antagonists (SERCAs) and complete ER antagonists (CERANs).
* Inadequate liver, kidney and bone marrow function
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Refractory nausea and vomiting, inability to swallow capsules and tablets whole, chronic gastrointestinal diseases, significant gastric (total or partial) or bowel resection that would preclude adequate absorption of study interventions.
* Current use or anticipated need for food, herbal supplements or drugs that are known strong CYP3A4 inhibitors or inducers.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/07/2030
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Actual
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Sample size
Target
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Accrual to date
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Final
1180
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Cancer Research SA - Adelaide
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Recruitment hospital [2]
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Cabrini Hospital -Brighton - Brighton
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Recruitment hospital [3]
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Barwon Health - Geelong
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Recruitment hospital [4]
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Cabrini Hospital - Malvern - Malvern
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3186 - Brighton
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3144 - Malvern
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Recruitment outside Australia
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United States of America
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State/province [1]
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Florida
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United States of America
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State/province [2]
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Michigan
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United States of America
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Missouri
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United States of America
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Tennessee
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United States of America
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State/province [5]
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Virginia
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Brazil
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State/province [6]
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Espírito Santo
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Country [7]
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Brazil
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State/province [7]
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RIO Grande DO SUL
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Country [8]
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Brazil
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State/province [8]
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SÃO Paulo
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China
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State/province [9]
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Beijing
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China
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Guangdong
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China
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Hubei
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China
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Shaanxi
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China
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Zhejiang
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Hungary
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Debrecen
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Italy
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Campania
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Italy
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Emilia-romagna
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Italy
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Lombardia
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Tokyo
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Slovakia
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Partizanske
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Slovakia
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Presov
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Spain
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Barcelona [barcelona]
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Spain
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Catalunya [cataluña]
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Spain
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Jaén
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Spain
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Málaga
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Spain
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Granada
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Spain
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Madrid
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Switzerland
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Aargau
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Switzerland
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Vaud
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Arvinas Estrogen Receptor, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: * Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. * Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. * Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT05909397
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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/NCT05909397