VERITAC-2
Research type
Research Study
Full 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)
IRAS ID
1006872
Contact name
Carlo Bello
Contact email
Sponsor organisation
Pfizer Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Patients are being asked to take part in this study because they have been diagnosed with locoregional recurrent/metastatic breast cancer that cannot be treated by surgery or radiation therapy with curative intent (called ‘advanced breast cancer’). The cancer has worsened after previous treatment(s), and it is sensitive to hormonal therapy (called oestrogen receptor positive, or ER+). The tumour cells do not express a marker (HER2 protein), therefore it is called HER2 negative.
This study will explore the efficacy and the safety of an investigational drug called ARV-471 (PF-07850327) compared to fulvestrant to find out which is better for treating advanced breast cancer. Efficacy assessment looks at how well the drug works, and safety assessment looks at how well it is tolerated.
If the patients join the study, they will be assigned by chance (like the flip of a coin) to receive either ARV-471 or fulvestrant.
The patients may be in this study (including treatment period and post-treatment period) for approximately 36 months.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0189
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion