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Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib

Study acronym: NoLEEta
StatusRecruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 110 → 138 locationsv4
  2. Trial sites expanded: 70 → 110 locationsv3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 39 to 70 · Start date changed from estimate of Dec 1, 2025 to Dec 18, 2025 · Interventions: Chemotherapy (Drug), De-escalation (Other) to Chemotherapy followed by endocrine therapy and ribociclib treatment (Drug), De-escalation (Other)v2 Show 3 more changesShow less
    • Study sites: 39 to 70
    • Start date changed from estimate of Dec 1, 2025 to Dec 18, 2025
    • Interventions: Chemotherapy (Drug), De-escalation (Other) to Chemotherapy followed by endocrine therapy and ribociclib treatment (Drug), De-escalation (Other)
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+/HER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ /HER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4/6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.
Trial Details
NCT Number NCT07237256
Lead Sponsor UNICANCER
Collaborators: Novartis, SOLTI Breast Cancer Research Group, GBG Forschungs GmbH, Latin American Cooperative Oncology Group, Gruppo Italiano Mammella (GIM), BOOG Study Center, Canadian Cancer Trials Group, Swiss Cancer Institute, Menarini Silicon Biosystems, INC
Conditions Breast Cancer
Enrollment 3,902 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov