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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Patients will receive the standard dose of camizestrant once daily as oral tablets
Patients will receive the standard dose of ribociclib once daily as oral tablets
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death. The primary measure of interest is the TTNT event-free rate at 2 years.
Time frame: Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
TTD is defined as time from the date of the first administration of study treatment to the earliest date of camizestrant treatment discontinuation or death. The primary measure of interest is the TTD event-free rate at 2 years.
Time frame: Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment
Efficacy of camizestrant and ribociclib by progression free survival (PFS)
PFS is defined as time from first dose of study treatment until progression per RECIST 1.1 as assessed by investigator or death due to any cause. The primary measures of interest are the PFS event-free rates at 1 and 2 years.
Time frame: Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.
CTCAE grade ≥ 3 associated with camizestrant and ribociclib within first 6 months of study treatment
Incidence of Grade \>=3 CTCAEs associated with Camizestrant and/or Ribo within first 6 months of receiving study treatment.
Time frame: Following first dose of study treatment until 6 months later
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Duarte, California, United States
NOT_YET_RECRUITINGResearch Site
Palo Alto, California, United States
NOT_YET_RECRUITINGResearch Site
Marietta, Georgia, United States
RECRUITINGResearch Site
Evanston, Illinois, United States
NOT_YET_RECRUITINGResearch Site
Edgewood, Kentucky, United States
NOT_YET_RECRUITINGResearch Site
Louisville, Kentucky, United States
NOT_YET_RECRUITINGResearch Site
Reno, Nevada, United States
NOT_YET_RECRUITINGResearch Site
Sioux Falls, South Dakota, United States
NOT_YET_RECRUITINGResearch Site
Nashville, Tennessee, United States
NOT_YET_RECRUITINGResearch Site
Fort Worth, Texas, United States
NOT_YET_RECRUITING...and 79 more locations