A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

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) - VERITAC-2

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220651

Enrollment

560

Registered

2023-02-22

Start date

2023-03-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ER+/HER2 Advanced Breast Cancer

Interventions

Drug: ARV-471 orally, once daily on a 28-day continuous dosing schedule Other Name: PF-07850327 Drug: Fulvestrant intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 *=6 months prior to disease progression *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

Exclusion criteria

Exclusion criteria: 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, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting *other investigational novel endocrine therapy (ie, SERD, SERCA, CERAN) for any setting *prior CDK4/6 inhibitor treatment in the neoadjuvant/ adjuvant setting *prior chemotherapy for advanced/metastatic disease *Inadequate liver, kidney and bone marrow function *Active brain metastases *Participants with significant concomitant illness

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures : 1.Progression Free Survival (PFS) [ Time Frame: 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). ] 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) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.	—

Measure

Time frame

Primary Outcome Measures : 1.Progression Free Survival (PFS) [ Time Frame: 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). ] 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) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.

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Secondary

Measure	Time frame
Secondary Outcome Measures : 1.Overall survival (OS) [ Time Frame: From randomization date (every 3 months) to date of death (approximately 3 years) ] Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause. 2.Objective Response Rate (ORR) [ Time Frame: 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). ] Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first. 3.Duration of response (DR) [ Time Frame: 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). ] Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first. 4.Clinical Benefit Rate [ Time Frame: 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). ] Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first. 5.Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities [ Time Frame: From screening until 28 days after the last dose (approximately 2 years). ] Incidence of participants with TEAEs, SAE	—

Measure

Time frame

Secondary Outcome Measures : 1.Overall survival (OS) [ Time Frame: From randomization date (every 3 months) to date of death (approximately 3 years) ] Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause. 2.Objective Response Rate (ORR) [ Time Frame: 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). ] Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first. 3.Duration of response (DR) [ Time Frame: 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). ] Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first. 4.Clinical Benefit Rate [ Time Frame: 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). ] Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first. 5.Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities [ Time Frame: From screening until 28 days after the last dose (approximately 2 years). ] Incidence of participants with TEAEs, SAE

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Countries

Japan, Puerto Rico, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026