Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer

Sponsor
Yeon Hee Park
Study ID
NCT06849947
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib with fulvestrant — DRUG
    ▪ Ribociclib group \- Ribociclib (600 mg orally once daily on days 1 to 21 in a 28 day cycle) + Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day 15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)
  • Physician's choice treatments group — DRUG
    ▪Fulvestrant or exemestane group 1. Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or periomenopausal women) OR, 2. Exemestane (25 mg orally once daily on day 1 to 28 in a 28 day cycle) + Everolimus (10 mg orally once daily on day 1 to 28 in a 28 day cycle) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)

Study Details

▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment

Key Dates

Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib group
    ▪ Ribociclib group \- Ribociclib (600 mg orally once daily on days 1 to 21 in a 28 day cycle) + Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day 15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)
  • Active Comparator: Physician's choice treatments group
    ▪ Fulvestrant or exemestane group 1. Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or periomenopausal women) OR, 2. Exemestane (25 mg orally once daily on day 1 to 28 in a 28 day cycle) + Everolimus (10 mg orally once daily on day 1 to 28 in a 28 day cycle) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 5 years ]

Central Contacts

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