A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
Qualifiers
Capable of giving signed informed consent.
Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.
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.
Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
Disqualifiers
Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
Persistent treatment-induced non-haematological toxicities (CTCAE Grade > 2).
Trial design
Treatments tested in this trial
- Camizestrant
- Ribociclib
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
AstraZeneca
Lead sponsor
ICON plc
Collaborator
Source ClinicalTrials.gov