A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT07647328
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • ER-Positive HER2-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Camizestrant — DRUG
    Patients will receive the standard dose of camizestrant once daily as oral tablets
  • Ribociclib — DRUG
    Patients will receive the standard dose of ribociclib once daily as oral tablets

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
May 2026
Primary completion
Apr 20, 2028
Completion
Apr 10, 2034

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camizestrant and Ribociclib
    Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets

Primary Outcome Measure

Efficacy of camizestrant and ribociclib by time to next treatment (TTNT) [ Time Frame: Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment. ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SitePalo AltoCalifornia94304-
Research SiteMariettaGeorgia30060-
Research SiteEvanstonIllinois60201-
Research SiteEdgewoodKentucky41017-
Research SiteLouisvilleKentucky40202-
Research SiteRenoNevada89502-
Research SiteSioux FallsSouth Dakota57105-
Research SiteNashvilleTennessee37204-
Research SiteFort WorthTexas76104-
Research SiteKingwoodTexas77339-
Research SiteMidlothianVirginia23114-

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