NCT02732119 (TRINITI-1) is a Phase 1, PHASE2 clinical trial of Ribociclib in Breast Cancer, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02732119?

NCT02732119 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02732119?

Interventions in NCT02732119: Ribociclib, Everolimus, Exemestane.

What condition does NCT02732119 study?

NCT02732119 studies Breast Cancer.

Is NCT02732119 still recruiting?

NCT02732119 is currently completed. Last updated 5 May 2021.

Are results published for NCT02732119?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-05 · How we verify

NCT02732119: TRINITI-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

Completed Phase 1, PHASE2 Results posted Last updated 5 May 2021

What this trial tests

Phase 1, PHASE2 trial testing Ribociclib in Breast Cancer in 104 participants. Completed in 25 February 2020.

Timeline

14 June 2016

Primary endpoint
25 February 2020

25 February 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	14 June 2016
Primary completion	25 February 2020
Estimated completion	25 February 2020
Sites	25 locations across United States

Drugs / interventions tested

Ribociclib (ribociclib) — full drug profile →
Everolimus (everolimus) — full drug profile →
Exemestane (exemestane) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

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.

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I Primary · Baseline up to 28 days

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a reasonably possible relationship to the study medication(s) and is unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) and meets any of the criteria defined in the protocol. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.

Febrile neutropenia Grade 3

Group	Value	95% CI
Cohort A	1
Cohort B	1
Cohort C	0

Neutropenia Grade 4

Group	Value	95% CI
Cohort A	0
Cohort B	1
Cohort C	0

Thrombocytopenia Grade 4

Group	Value	95% CI
Cohort A	0
Cohort B	1
Cohort C	0

Cardiac tamponade Grade 4

Group	Value	95% CI
Cohort A	1
Cohort B	0
Cohort C	0

Diarrhea Grade 3

Group	Value	95% CI
Cohort A	1
Cohort B	0
Cohort C	0

Hyperglycemia Grade 4

Group	Value	95% CI
Cohort A	0
Cohort B	0
Cohort C	1

Clinical Benefit Rate as Per Central Review by Group- Phase II Primary · From baseline up to 24 weeks

Clinical Benefit Rate (CBR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) or with stable disease (SD) as per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 or Non-Complete Response or Non-Progressive Disease (NCRNPD) during first 24 weeks of first dose. CR=disappearance of all non-nodal target lesions, PR=at least a 30% decrease in the sum of diameter of all target lesions, SD=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD), PD=at least a 20% increa

Overall response rate (CR+PR):

Group	Value	95% CI
Group 1	6.5	1.4 – 17.9
Group 2	9.4	2.0 – 25.0

CBR - CR+PR+SD (NCRNPD) by 24 weeks

Group	Value	95% CI
Group 1	65.2	49.8 – 78.6
Group 2	59.4	40.6 – 76.3

Disease control rate (CR+PR+SD(NCRNPD)

Group	Value	95% CI
Group 1	65.2	49.8 – 78.6
Group 2	59.4	40.6 – 76.3

Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II Primary · Baseline up to 24 weeks and at 24 weeks

Complete response (CR) or partial response (PR), or stable disease (SD) at 24 weeks as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Non-CR Non-PD (NCRNPD) at Week 24.

Participants with measurable disease at baseline

Group	Value	95% CI
Group 1	35
Group 2	21

Participants with non-measurable disease at baseline

Group	Value	95% CI
Group 1	11
Group 2	11

Complete response (CR)

Group	Value	95% CI
Group 1	0
Group 2	0

Partial Response (PR)

Group	Value	95% CI
Group 1	3
Group 2	3

Stable disease (SD)

Group	Value	95% CI
Group 1	17
Group 2	6

Progressive disease (PD)

Group	Value	95% CI
Group 1	14
Group 2	12

NCRNPD - Non-complete response non-progressive disease

Group	Value	95% CI
Group 1	10
Group 2	10

Unknown

Group	Value	95% CI
Group 1	2
Group 2	1

Everolimus Pharmacokinetic Plasma Concentrations by Cohort - Phase I Secondary · Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose

Plasma concentrations; below limit of quantitation values set to zero

Cycle 1, Day 15 Pre-dose

Group	Value	95% CI
Cohort A	7.82	3.57 – 10.3
Cohort B	8.31	1.68 – 14.8
Cohort C	8.28	5.25 – 15.0

Cycle 1, Day 15 2 H, post dose

Group	Value	95% CI
Cohort A	15.2	13.2 – 36.2
Cohort B	17	6.84 – 34.4
Cohort C	36.2	19.4 – 63.4

Cycle 1, Day 15 4 H, post dose

Group	Value	95% CI
Cohort A	17.7	16.7 – 18.5
Cohort B	16.2	4.69 – 20.7
Cohort C	21.5	13.6 – 35.8

Cycle 2, Day 1 Pre-dose

Group	Value	95% CI
Cohort A	6.47	5.63 – 11.5
Cohort B	6.22	1.71 – 10.5
Cohort C	7.76	4.58 – 15.4

Cycle 2, Day 15 Pre-dose

Group	Value	95% CI
Cohort A	5.89	4.33 – 9.52
Cohort B	4.26	0.82 – 8.02
Cohort C	7.17	5.4 – 15.3

Cycle 2, Day 15 2 H post-dose

Group	Value	95% CI
Cohort A	21.8	13.5 – 33.3
Cohort B	14.5	8.67 – 30.1
Cohort C	22.1	10.4 – 72.0

Cycle 2, Day 15 4 H post-dose

Group	Value	95% CI
Cohort A	13.7	5.42 – 20.7
Cohort B	9.13	6.62 – 15.7
Cohort C	26.9	20.5 – 41.1

Cycle 3, Day 1 4 H pre-dose

Group	Value	95% CI
Cohort A	4.7	3.05 – 9.98
Cohort B	6.97	2.87 – 22.5
Cohort C	6.33	4.8 – 7.85

Best Overall Responses (BOR) Summary Table as Per Central Review by Cohort - Phase I Secondary · From baseline up to 24 weeks

Complete response (CR) or partial response (PR), or stable disease (SD)as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Non-CR Non-PD (NCRNPD)

Participants with measurable disease at baseline

Group	Value	95% CI
Cohort A	5
Cohort B	7
Cohort C	4

Participants with non-measurable disease at baseline

Group	Value	95% CI
Cohort A	3
Cohort B	3
Cohort C	3

Complete response (CR)

Group	Value	95% CI
Cohort A	0
Cohort B	0
Cohort C	0

Partial Response (PR)

Group	Value	95% CI
Cohort A	0
Cohort B	1
Cohort C	2

Stable disease (SD)

Group	Value	95% CI
Cohort A	3
Cohort B	6
Cohort C	2

Progressive disease (PD)

Group	Value	95% CI
Cohort A	3
Cohort B	0
Cohort C	0

NCRNPD - Non-complete response non-progressive disease

Group	Value	95% CI
Cohort A	2
Cohort B	1
Cohort C	3

Unknown

Group	Value	95% CI
Cohort A	0
Cohort B	2
Cohort C	0

Clinical Benefit Rate as Per Central Review by Dose Cohort - Phase I Secondary · Baseline up to 24 weeks and at week 24

Clinical Benefit Rate (CBR) is defined as the percentage of patients with a complete response (CR) or partial response (PR) or with stable disease (SD) at 24 weeks as per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 or Non-Complete Response Non-Progressive Disease (NCRNPD) up to Week 24 and at Week 24.

Overall response rate (CR+PR):

Group	Value	95% CI
Cohort B	10.0	0.3 – 44.5
Cohort C	28.6	3.7 – 71.0

CBR - CR+PR+SD (NCRNPD) by 24 weeks

Group	Value	95% CI
Cohort A	62.5	24.5 – 91.5
Cohort B	80.0	44.4 – 97.5
Cohort C	100.0	59.0 – 100

CBR - CR+PR+SD (NCRNPD) at 24 weeks

Group	Value	95% CI
Cohort A	0	0.0 – 36.9
Cohort B	0.0	0.0 – 30.8
Cohort C	28.6	3.7 – 71.0

Disease control rate (CR+PR+SD(NCRNPD)

Group	Value	95% CI
Cohort A	62.5	24.5 – 91.5
Cohort B	80.0	44.4 – 97.5
Cohort C	100	59.0 – 100

Summary of Progression-free Survival (PFS) (Months), as Per Central Review by Group - Phase II Secondary · Baseline up to approximately 32 months

Progression is defined as \<= 12 weeks after randomization/ start of treatment (and not qualifying for CR, PR or SD).

Group	Value	95% CI
Group 1	8.0	3.8 – 14.5
Group 2	4.7	2.0 – 12.7

Overall Survival (OS) by Group - Phase II Secondary · Baseline up to approximately 32 months

Overall survival is the time from date of first treatment to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the last date of contact.

Group	Value	95% CI
Group 1	27.4	16.8 – NA
Group 2	NA	16.4 – NA

Duration of Overall Response (DOR) by Group - Phase II Secondary · Baseline up to approximately 16 months

Patients whose best response is complete response (CR) or partial response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of first documented progression or death due to underlying cancer.

Group	Value	95% CI
Group 1	14.6	NA – NA
Group 2	6.4	5.5 – 7.4

Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score by Group - Phase II Secondary · Baseline up to approximately 8 months

Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.

Group	Value	95% CI
Group 1	NA	7.4 – NA
Group 2	12.0	7.3 – NA

Everolimus Pharmacokinetic Plasma Concentrations - Phase II Secondary · Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose

Plasma concentrations; below limit of quantitation values set to zero

Cycle 1, Day 15 pre dose

Group	Value	95% CI
Group 1	214	13.8 – 1410
Group 2	132	45.2 – 296

Cycle 1, Day 15 2 H post-dose

Group	Value	95% CI
Group 1	644	38.6 – 2490
Group 2	372	83.8 – 686

Cycle 1, Day 15 4 H post-dose

Group	Value	95% CI
Group 1	583	34.3 – 2320
Group 2	323	81.3 – 631

Cycle 2 Day 1 pre-dose

Group	Value	95% CI
Group 1	199	2.27 – 691
Group 2	125	1.4 – 379

Cycle 2, Day 15 pre-dose

Group	Value	95% CI
Group 1	245	21.2 – 1350
Group 2	170	2.72 – 382

Cycle 2, Day 15 2 H post-dose

Group	Value	95% CI
Group 1	652	140 – 2260
Group 2	442	2.34 – 1240

Cycle 2, Day 15 4 H post-dose

Group	Value	95% CI
Group 1	642	133 – 2130
Group 2	406	2.1 – 1040

Cycle 3, Day 1 pre-dose

Group	Value	95% CI
Group 1	193	1.52 – 1080
Group 2	198	2.61 – 504

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 108 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A

Serious: 3/8 (38%)

Deaths: 6/8

Cohort B

Serious: 3/10 (30%)

Deaths: 5/10

Cohort C

Serious: 5/7 (71%)

Deaths: 0/7

Group 1

Serious: 11/46 (24%)

Deaths: 20/46

Group 2

Serious: 5/33 (15%)

Deaths: 11/33

Serious adverse events (50 terms)

Reaction	System	Cohort A	Cohort B	Cohort C	Group 1	Group 2
Pyrexia	General disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—
Cardiac tamponade	Cardiac disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Pneumatosis intestinalis	Gastrointestinal disorders	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—

Other adverse events (163 terms — click to expand)

Reaction	System	Cohort A	Cohort B	Cohort C	Group 1	Group 2
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Neutropenia, Nausea, Sepsis, Headache, Pneumonitis, Anaemia, Febrile neutropenia.

Data from ClinicalTrials.gov NCT02732119 adverse events section.

Sponsor's own description

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3
ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer.
Brett JO, Spring LM, Bardia A, Wander SA. · · 2021 · cited 266× · PMID 34392831 · DOI 10.1186/s13058-021-01462-3
Activation of PI3K/AKT/mTOR Pathway Causes Drug Resistance in Breast Cancer.
Dong C, Wu J, Chen Y, Nie J, et al · · 2021 · cited 260× · PMID 33790792 · DOI 10.3389/fphar.2021.628690
The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies.
Knudsen ES, Witkiewicz AK. · · 2017 · cited 218× · PMID 28303264 · DOI 10.1016/j.trecan.2016.11.006
CDK4/6 inhibition in breast cancer: current practice and future directions.
Pernas S, Tolaney SM, Winer EP, Goel S. · · 2018 · cited 212× · PMID 30038670 · DOI 10.1177/1758835918786451
Ribociclib (LEE011): Mechanism of Action and Clinical Impact of This Selective Cyclin-Dependent Kinase 4/6 Inhibitor in Various Solid Tumors.
Tripathy D, Bardia A, Sellers WR. · · 2017 · cited 184× · PMID 28351928 · DOI 10.1158/1078-0432.ccr-16-3157
Endocrine Resistance in Hormone Receptor Positive Breast Cancer-From Mechanism to Therapy.
Rani A, Rani A, Stebbing J, Giamas G, et al · · 2019 · cited 162× · PMID 31178825 · DOI 10.3389/fendo.2019.00245
Targeting Cell Cycle in Breast Cancer: CDK4/6 Inhibitors.
Piezzo M, Cocco S, Caputo R, Cianniello D, et al · · 2020 · cited 128× · PMID 32899866 · DOI 10.3390/ijms21186479

Verify or expand the search:

Other trials of Ribociclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · 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 · Phase 2 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02732119 (US National Library of Medicine, public domain)
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: 5 May 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/NCT02732119.

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