Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT05296746
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Breast Cancer Stage II

Eligibility Criteria

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

Interventions

  • Ribociclib (neoadjuvant) — DRUG
    Ribociclib 600 mg/day + letrozole during neoadjuvant phase.
  • Chemotherapy (adjuvant) — DRUG
    Adjuvant chemotherapy. 3 regimens are permitted.
  • Ribociclib (adjuvant) — DRUG
    Ribociclib 400 mg/day + letrozole (or other aromatase inhibitor) during adjuvant phase.

Study Details

This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

Key Dates

Start date
May 3, 2022
Status verified
May 2026
Primary completion
Oct 1, 2029
Completion
Dec 1, 2031

Study Design

Enrollment
1,100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Responder (ROR-low)
    Ribociclib (400 mg/day; 3 weeks ON and 1 week OFF) in the adjuvant setting for 33 cycles. Letrozole or other aromatase inhibitor treatment duration must be of at least 5 years
  • Other: Non-responder (ROR-medium/high)
    Adjuvant chemotherapy. 3 regimens are permitted. Regimen 1: \- Doxorubicin 60 mg/m2 IV day 1 (or Epirubicin 75-100 mg/m2) and Cyclophosphamide 600-830 mg/m2 day 1 every 14/21 days for 4 cycles, followed by Paclitaxel 80 mg/m2 every week for 12 weeks or Docetaxel 75-100 mg/m2 every 3 weeks for 12 weeks. Regimen 2: \- Docetaxel 75-100 mg/m2 IV day 1 and Cyclophosphamide 600-830 mg/m2 day 1 every 21 days for 4-6 cycles. Regimen 3: \- Paclitaxel 80 mg/m2 every week for 12 weeks or Docetaxel 75-100 mg/m2 every 3 weeks for 12 weeks followed by Doxorubicin 60 mg/m2 IV day 1 (or Epirubicin 75-100 mg/m2) and Cyclophosphamide 600-830 mg/m2 day 1 every 14/21 days for 4 cycles. Then, patients will receive ribociclib (400 mg/day; 3 weeks ON and 1 week OFF) in the adjuvant setting for 33 cycles. Letrozole or other aromatase inhibitor treatment duration must be of at least 5 years

Primary Outcome Measure

Distant metastasis-free survival (DMFS) in the ROR-low cohort (responder cohort) [ Time Frame: Until recurrence (if it happens) for a maximum of 7.5 years of follow-up ]

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