drugset / Trial / NCT03283384
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
Phase 2
Active not recruiting
100 enrolled
Dutch Breast Cancer Research Group
Novartis · collabPhilips Healthcare · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2019-06-15
- Primary completion
- 2022-12-06
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Letrozole | Other / unclassified | 2.5 mg | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Ribociclib | Small molecule | 600 mg | — |