18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events and Serious Adverse EventsPrimary· Up to 26 months
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Adverse Events
Group
Value
95% CI
Ribociclib + Adjuvant Endocrine Therapy (ET)
25
Placebo + Adjuvant Endocrine Therapy (ET)
21
Serious Adverse Events
Group
Value
95% CI
Ribociclib + Adjuvant Endocrine Therapy (ET)
4
Placebo + Adjuvant Endocrine Therapy (ET)
2
Percentage of Participants With Adverse Events and Serious Adverse EventsPrimary· Up to 26 months
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Adverse Events
Group
Value
95% CI
Ribociclib + Adjuvant Endocrine Therapy (ET)
96.2
Placebo + Adjuvant Endocrine Therapy (ET)
87.5
Serious Adverse Events
Group
Value
95% CI
Ribociclib + Adjuvant Endocrine Therapy (ET)
15.4
Placebo + Adjuvant Endocrine Therapy (ET)
8.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ribociclib + Adjuvant Endocrine Therapy (ET)
Serious: 4/26 (15%)
Deaths: 0/26
Placebo + Adjuvant Endocrine Therapy (ET)
Serious: 2/24 (8%)
Deaths: 0/24
Serious adverse events (7 terms)
Reaction
System
Ribociclib + Adjuvant Endo…
Placebo + Adjuvant Endocri…
Disseminated intravascular coagulation
Blood and lymphatic system disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Breast cellulitis
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT06905301 — Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and W
· recruiting
NCT06930859 — Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Recepto
· recruiting
NCT07054190 — A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
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· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 11 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03078751.