A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Summary
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).
Timeline
- Start
- 2018-12-07
- Primary completion
- 2030-05-29
- Completion
- 2030-05-29
Outcome
Met primary endpoint
paper A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. PMID 38507751 ↗
paper hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003. PMID 38507751 ↗
release “Kisqali Ph3 NATALEE trial showed that ribociclib plus a non-steroidal aromatase inhibitor (NSAI), compared to NSAI alone, significantly lowered the risk of cancer recurrence” sandoz.com ↗
release “pivotal Phase III NATALEE trial, which showed a significant and clinically meaningful 25.1%” novartis.com ↗
release “This invasive disease-free survival (iDFS) benefit was also consistent across all pre-specified patient subgroups” novartis.com ↗
release “reducing the risk of recurrence by 28.5% (HR=0.715; 95% CI 0.609–0.840; P <0.0001)” novartis.com ↗
release “Phase III NATALEE data showing Kisqali ® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit” novartis.com ↗
release “NATALEE trial in the broadest population of high-risk stage II and III HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy (ET) reduced the risk of recurrence by 28.4%” novartis.com ↗
Publications
- Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.
- Fasching PA, Stroyakovskiy D, Yardley DA, Huang CS, Crown J, Bardia A, Chia S, Im SA, Martin M, Xu B, Loi S, Barrios C, Untch M, Moroose R, Visco F, Hortobagyi GN, Slamon DJ, Fresco R, Zarate JP, Li Z, Waters S, Hurvitz SA. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1364-1372. doi: 10.1001/jamaoncol.2025.3700.
- Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488.
- Slamon DJ, Fasching PA, Hurvitz S, Chia S, Crown J, Martin M, Barrios CH, Bardia A, Im SA, Yardley DA, Untch M, Huang CS, Stroyakovskiy D, Xu B, Moroose RL, Loi S, Visco F, Bee-Munteanu V, Afenjar K, Fresco R, Taran T, Chakravartty A, Zarate JP, Lteif A, Hortobagyi GN. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023 May 29;15:17588359231178125. doi: 10.1177/17588359231178125. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 400 mg | Oral |