CADILLAC
INTERNATIONAL, MULTICENTER, OPEN-LABEL, HISTORICAL-CONTROLLED PHASE II TRIAL DESIGNED TO EVAUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER.
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TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
Breast Cancer
II
≥ 300
28
Spain, Germany & China
Recruiting
CLINICAL TRIAL DETAILS
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CADILLAC is a international, multicenter, open-label, historical-controlled phase II trial designed to evaluate the efficacy and safety of camizestrant plus ribociclib in in patients with HR-positive/HER2‑negative advanced breast cancer.
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Patients will receive camizestrant in combination with ribociclib (experimental arm, n=150). Clinical outcomes will be compared with outcomes from a historical control arm of at least 150 patients treated with ribociclib plus aromatase inhibitors or fulvestrant.
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The primary objective is to assess the progression-free survival (PFS). Key secondary endpoints are overall response rate (ORR), clinical benefit rate (CBR), quality of life, and safety. PFS, ORR, and CBR will be locally assessed by the investigators using RECIST v.1.1.
CADILLAC AT CLINICALTRIALS.GOV
TRIAL RESUME
