OPERA-01
Research type
Research Study
Full title
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)
IRAS ID
1008665
Contact name
Jennifer Richards
Contact email
Sponsor organisation
Olema Pharmaceuticals, Inc.
Eudract number
2023-505871-63
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test how safe a new drug, called OP-1250 (also known as palazestrant), is for treating people with ER+, HER2- advanced or metastatic breast cancer and to test if it is better or worse than the usual standard of care treatment for this type of breast cancer. The Sponsor would like to find out what effects the drug has, both good and bad, on participants this disease.
Approximately 510 male and female participants aged 18 and over will take part in this study. This study will be conducted at approximately 210 globally. This study will continue for approximately 40 to 45 months.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0981
Date of REC Opinion
29 Jan 2024
REC opinion
Further Information Favourable Opinion