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Clinical trial · no report yet · Phase 2
AMALEE trial (ribociclib): what clinicians have said so far
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
- NCT03822468 ↗
- Completed
- Novartis Pharmaceuticals
- Focused size, estimated: 1–150 verified statements once built
We haven't built an HCP commentary report on AMALEE (ribociclib in first-line HR-positive HER2-negative advanced breast cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on AMALEE so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 2 posts on X, typically up to 9 once built | |
| 1 podcast episode, typically up to 4 once built |
The trial
ClinicalTrials.gov- Official title
- A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
- Phase
- Phase 2
- Status
- Completed
- Conditions
- Breast Cancer
- Interventions
- Ribociclib; Anastrozole; Letrozole; Goserelin
- Arms
- Ribociclib 400 mg · Experimental
- Ribociclib 600 mg · Active comparator
- Enrollment
- 376
- Primary outcomes
- Overall Response Rate (ORR)
- Sponsor
- Novartis Pharmaceuticals
- Start
- Jun 11, 2019
- Primary completion
- Jun 11, 2021
- Results posted
- Yes
- Registry record
- NCT03822468 · updated Oct 16, 2025
Publications
linked from the registry- 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. PubMed 42334791
- Cardoso F, Jacot W, Kuemmel S, Gupta S, Cruz F, Balaraman R, Ferreira A, Ahola T, Chapko Y, Zhukova L, Chiang W, Li Z, Ji Y, Kaakiou N, Bolotova N, Sparano JA. 600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1356-1363. doi: 10.1001/jamaoncol.2025.3687. PubMed 40996770