A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
Confirmed diagnosis of ER positive breast cancer
No prior systemic anti-cancer therapy for advanced ER+ disease
Postmenopausal women
Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
Eastern Cooperative Oncology Group \[ECOG\] 0-1
Adequate organ and marrow function
Patient must agree to provide tumor tissue
You may not be if
Confirmed diagnosis of HER2 positive disease
Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Known uncontrolled or symptomatic CNS metastases
Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
Prior treatment with any CDK 4/6 inhibitor
Clareo Health | A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]