Randomized, open Phase III study of ARV-471 (PF-07850327) plus Palbociclib compared to Letrozole plus Palbociclib in patients with advanced ER(+)/HER2(-) breast cancer (VERITAC-3)

Kriterien zur Teilnahme
Participants aged 18 years or older (or the minimum age of protection according to local regulations) at screening. Participants who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures. Female participants under 60 years of age, with absence of regular menstruation for 12 consecutive months and without other alternative medical cause must have an FSH level within the postmenopausal range, according to local laboratory reference range. ONLY Phase 3. Participants must provide a blood sample AND a tumor sample at the time of diagnosis of a locally advanced/metastatic disease. (BASEC)

Ausschlusskriterien
Other medical or psychiatric conditions, including new (within the last year) or active conditions Suicidal thoughts/behaviors or laboratory abnormalities that may increase the risk of study participation or, in the opinion of the investigator, make the participant unsuitable for the study. Any other solid tumors within the last 3 years, except for the following: 1) adequately treated basal or squamous cell carcinoma of the skin; and 2) in situ curatively treated cervical carcinoma. For all other solid tumors, they must have been curatively treated and without disease symptoms for > 3 years. Participants with inflammatory BC, previous hematopoietic stem cell or bone marrow transplant are excluded. Participants with newly diagnosed brain metastases or central nervous system symptoms (CNS), carcinomatous meningitis or leptomeningeal disease indicated by clinical symptoms, brain edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (e.g., radiation therapy, stereotactic surgery), are clinically stable (including participants with residual CNS symptoms/deficits), and not on enzyme-inducing anticonvulsants and steroids for at least 14 days prior to randomization. (BASEC)