SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients
AstraZeneca
Summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.
Description
This global, multicenter, Phase IIIb, single-arm study will evaluate the efficacy, safety, and tolerability of camizestrant combined with ribociclib in patients with ER+ HER2- advanced breast cancer who have not previously received systemic therapy for advanced disease. Approximately 150 participants will be enrolled, and all enrolled participants will receive standard daily oral doses of camizestrant 75 mg and ribociclib 600 mg until treatment discontinuation.
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Capable of giving signed informed consent. 2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening. Type of Participant and Disease Characteristics 3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent. 4. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease. 5. De novo Stage 4 disease, or recurrence from early CD stage breast cancer afte…
Interventions
- DrugCamizestrant
Patients will receive the standard dose of camizestrant once daily as oral tablets
- DrugRibociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
Locations (84)
- Research SiteDuarte, California
- Research SitePalo Alto, California
- Research SiteMarietta, Georgia
- Research SiteEvanston, Illinois
- Research SiteEdgewood, Kentucky
- Research SiteLouisville, Kentucky