Phase 2Active, not recruiting
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer. (NEOLBC)
- Sponsor
- Borstkanker Onderzoek Groep (Research network)
- Enrolment
- 100 planned
- Conditions
- Breast Neoplasms
- Interventions
- Letrozole; Chemotherapy; Ribociclib plus letrozole
- Ages
- adults, older adults
- Registry
- NCT03283384, EUCTR2017-000676-29
Full record on ClinicalTrials.gov
From the registry
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.
Primary outcomes
- Difference in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) between ribociclib plus letrozole and chemotherapy in the surgical specimen.
History
Study completion expected
Last registry update
Primary completion
Started
Registered