Phase 3, Randomized, Open-Label Study of ARV-471 (PF-07850327) Plus Palbociclib vs Letrozole Plus Palbociclib in Participants With ER(+)/HER2(-) Advanced Breast Cancer (VERITAC-3)

Phase 1

Recruiting

• Conditions: ER + /HER 2 - Advanced Breast Cancer; MedDRA version: 21.1Level: LLTClassification code: 10072737Term: Advanced breast cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: CTIS2022-500545-24-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.• Pre-peri menopausal female and male participants must agree on LHRH use. • WOCBP participants and male participants must agree on contraception., Phase 3 ONLY. Participants must provide a blood sample AND a tumor sample collected at the time of diagnosis of locally advanced/metastatic disease. If not available, a de novo biopsy is required. The sole exception is those patients with bone only disease for whom archival tumor sample at initial diagnosis is acceptable., Histological or cytological confirmation of BC with evidence of locoregionally advanced or metastatic disease, not amenable to surgical resection or radiation therapy with curative intent. •Documented ER(+), defined as ER(+) =1% stained cells on the most recent tumor biopsy, ie, at diagnosis of recurrence or metastatic disease (Allison et al, 2020). The sole exception is those patients with bone only disease for whom ER(+) using archival tissue at initial diagnosis is acceptable. •Documented HER2(-) tumor by either IHC or in-situ hybridization per ASCO/CAP guideline (Wolff et al, 2018). •Participants who have bilateral BCs which are both ER(+)/HER2(-) are eligible., No prior systemic anti-cancer therapy for their locoregionally advanced or metastatic disease., At least 1 measurable lesion as defined by RECIST v1.1. Bone only disease: participants with only non-measurable lesions are eligible., Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2.

Exclusion Criteria

Prior treatments: •Primary endocrine resistance: relapse while on the first 2 years of standard adjuvant ET. •Secondary endocrine resistance: -relapse while on standard adjuvant ET but after the first 2 years -relapse within 12 months of completing standard adjuvant ET •CDK4/6i, ARV-471, fulvestrant, elacestrant and other investigational agents (including novel ET, any SERDs, SERCAs, CERANs) in any setting. •Participation in other studies involving investigational drug(s) within 28 days prior to randomization. If in the FU Phase, the participant is eligible provided at least 5 half-lives have elapsed from the last dose., Concurrent administration of medications, food or herbal supplements that are strong inhibitors or strong inducers of CYP3A. Prior use of strong CYP3A inhibitors must be stopped 7 days before randomization and strong CYP3A inducers must be stopped 14 days before randomization., Lack of adequate bone marrow, liver and kidney function., Impaired cardiovascular function or clinically significant cardiovascular diseases., Refractory nausea and vomiting, chronic GI disease, GI ulcer, GI bleeding, inability to swallow the formulated product or previous significant gastric (total or partial), bowel resection that would preclude adequate absorption of study interventions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified