Breast CancerPhase 1/2TRINITI-1NCT02732119

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

A Phase 1/2 study testing Ribociclib, Everolimus and Exemestane in people with Breast Cancer, run by Novartis Pharmaceuticals at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Ribociclib, Everolimus and Exemestane
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 25 sitesUnited States
Study dates: 14 Jun 2016to 25 Feb 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men and women
Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
ECOG Performance Status 0 - 1
Disease refractory to either, AI, tamoxifen or fulvestrant
Previously treated on any CDK 4/6 inhibitor.
Patient has adequate bone marrow and organ function.

Who cannot join

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
Patient has received more than one line of chemotherapy for advanced disease.
Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
Progressed on more than one CDK 4/6 inhibitor
Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
Clinically significant, uncontrolled heart disease and/or recent cardiac events.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Atlanta Cancer Center
Atlanta, Georgia
Massachusetts General Hospital Mass Gen Hos Cancer Center
Boston, Massachusetts, 02114
Ironwood Cancer and Research Centers Ironwood Cancer
Chandler, Arizona, 85224
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, 33328
Henry Ford Health System
Detroit, Michigan, 48202
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Florida Cancer Specialists FL Cancer Specialists
Fort Myers, Florida, 33901
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Oncology Consultants Oncology Consultants
Houston, Texas, 77024
MD Anderson Cancer Center/University of Texas MDACC
Houston, Texas, 77030
St. Luke's Cancer Institute Regulatory
Kansas City, Missouri, 64111
Research Medical Center HCA Midwest Division
Kansas City, Missouri, 64132
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
UCLA Department of Medicine UCLA Hematology/Oncology
Los Angeles, California, 90095
Sarah Cannon Research Institute Sarah Cannon Research Insti
Nashville, Tennessee, 37203
Yale University School of Medicine Smilow Cancer Hospital
New Haven, Connecticut, 06511
UF Health Cancer Center at Orlando Health UF Health (4)
Orlando, Florida, 32806
University of Pennsylvania Medical Center Abramson Cancer Ctr of the Uni
Philadelphia, Pennsylvania, 19104
Huntsman Cancer Institute Huntsman Cancer Insti
Salt Lake City, Utah, 84112
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, 94115
Central Coast Medical Oncology Corporation Onc Dept
Santa Maria, California, 93454
Washington University School of Medicine Washington U School of Medicin
St Louis, Missouri, 63110
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, 98405
University of Kansas Cancer Center Univ of KS CC Medical Pavilion
Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

Read the detailed description

This trial had two phases. The purpose of Phase I dose escalation and dose de-escalation was to determine the maximum tolerated doses (MTDs) and/or identify the recommended Phase II dose (RP2D) of the combination treatment of ribociclib+ everolimus + exemestane. The dosing was continuous in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer which was resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.

The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib combination therapy following progression on a CDK 4/6 inhibitor.

The planned duration of the study was 30 months.

Conditions: Breast Cancer
Being tested: Ribociclib, Everolimus, Exemestane
Keywords: HR-positive, HER2-negative, Advanced breast cancer, LEE011, ribociclib, everolimus, Afinitor, exemestane, Aromasin, CDK, CDK4, CDK6, CDK4/6, CDK4/6 inhibitor, Phase I, Phase II, ER-positive, PR-positive, Postmenopausal, adult
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RibociclibDrug
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
EverolimusDrug
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
ExemestaneDrug
supplied in 25 mg tablets taken orally, daily for 28 day cycle

Study groups in NCT02732119
Study group	Role	What they receive
Cohort A	Experimental	Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B Receives: Drug: Ribociclib; Drug: Everolimus; Drug: Exemestane
Cohort B	Experimental	Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally Receives: Drug: Ribociclib; Drug: Everolimus; Drug: Exemestane
Cohort C	Experimental	Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally Receives: Drug: Ribociclib; Drug: Everolimus; Drug: Exemestane
Group 1	Experimental	Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally Receives: Drug: Ribociclib; Drug: Everolimus; Drug: Exemestane
Group 2	Experimental	Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally Receives: Drug: Ribociclib; Drug: Everolimus; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I
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.
Measured: Baseline up to 28 days
Clinical Benefit Rate as Per Central Review by Group- Phase II
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% increase in the sum of diameter of all target lesions.
The hypothesis was to be rejected if the lower limit of the 95% Confidence Interval for Clinical Benefit Rate (CBR) was greater than 10%.
Measured: From baseline up to 24 weeks
Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II
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.
Measured: Baseline up to 24 weeks and at 24 weeks

Secondary outcomes (8)

Everolimus Pharmacokinetic Plasma Concentrations by Cohort - Phase I
Plasma concentrations; below limit of quantitation values set to zero
Measured: Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose
Best Overall Responses (BOR) Summary Table as Per Central Review by Cohort - Phase I
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)
Measured: From baseline up to 24 weeks
Clinical Benefit Rate as Per Central Review by Dose Cohort - Phase I
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.
Measured: Baseline up to 24 weeks and at week 24
Summary of Progression-free Survival (PFS) (Months), as Per Central Review by Group - Phase II
Progression is defined as <= 12 weeks after randomization/ start of treatment (and not qualifying for CR, PR or SD).
Measured: Baseline up to approximately 32 months
Overall Survival (OS) by Group - Phase II
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.
Measured: Baseline up to approximately 32 months
Duration of Overall Response (DOR) by Group - Phase II
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.
Measured: Baseline up to approximately 16 months
Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score by Group - Phase II
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.
Measured: Baseline up to approximately 8 months
Everolimus Pharmacokinetic Plasma Concentrations - Phase II
Plasma concentrations; below limit of quantitation values set to zero
Measured: Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201625 Feb 2020

First posted8 Apr 2016 (estimated)
Study start14 Jun 2016
Primary completion25 Feb 2020
Study completion25 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02732119
Sponsor's protocol ID: CLEE011XUS29
Acronym: TRINITI-1
Status last verified: Apr 2021
First submitted: 4 Apr 2016
Last updated: 5 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. his trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor
ClinicalTrials.gov ID: NCT02732119
Acronym / sponsor ID: TRINITI-1 / CLEE011XUS29
Conditions: Breast Cancer
Keywords: HR-positive, HER2-negative, Advanced breast cancer, LEE011, ribociclib, everolimus, Afinitor, exemestane
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 14 Jun 2016 (actual)
Primary completion: 25 Feb 2020 (actual)
Study completion: 25 Feb 2020 (actual)
First posted: 8 Apr 2016 (estimated)
Results: Posted 5 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib combination therapy following progression on a CDK 4/6 inhibitor.

The planned duration of the study was 30 months.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cohort A	Experimental	Drug: Ribociclib, Drug: Everolimus, Drug: ExemestaneRibociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
Cohort B	Experimental	Drug: Ribociclib, Drug: Everolimus, Drug: ExemestaneRibociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
Cohort C	Experimental	Drug: Ribociclib, Drug: Everolimus, Drug: ExemestaneRibociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
Group 1	Experimental	Drug: Ribociclib, Drug: Everolimus, Drug: ExemestaneRibociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
Group 2	Experimental	Drug: Ribociclib, Drug: Everolimus, Drug: ExemestaneRibociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adult men and women
Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
ECOG Performance Status 0 - 1
Disease refractory to either, AI, tamoxifen or fulvestrant

Key exclusion criteria (6 listed)

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
Patient has received more than one line of chemotherapy for advanced disease.
Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
Progressed on more than one CDK 4/6 inhibitor
Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ribociclibsupplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle	Drug	Cohort A, Cohort B, Cohort C, Group 1, Group 2
Everolimussupplied in 2.5 mg tablets taken orally, daily for 28 day cycle	Drug	Cohort A, Cohort B, Cohort C, Group 1, Group 2
Exemestanesupplied in 25 mg tablets taken orally, daily for 28 day cycle	Drug	Cohort A, Cohort B, Cohort C, Group 1, Group 2

Primary outcome

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I
Time frame: 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.
Clinical Benefit Rate as Per Central Review by Group- Phase II
Time frame: 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% increase in the sum of diameter of all target lesions. The hypothesis was to be rejected if the lower limit of the 95% Confidence Interval for Clinical Benefit Rate (CBR) was greater than 10%.
Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II
Time frame: 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.

8 secondary outcomes

Everolimus Pharmacokinetic Plasma Concentrations by Cohort - Phase I
Time frame: Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose
Best Overall Responses (BOR) Summary Table as Per Central Review by Cohort - Phase I
Time frame: From baseline up to 24 weeks
Clinical Benefit Rate as Per Central Review by Dose Cohort - Phase I
Time frame: Baseline up to 24 weeks and at week 24
Summary of Progression-free Survival (PFS) (Months), as Per Central Review by Group - Phase II
Time frame: Baseline up to approximately 32 months
Overall Survival (OS) by Group - Phase II
Time frame: Baseline up to approximately 32 months
Duration of Overall Response (DOR) by Group - Phase II
Time frame: Baseline up to approximately 16 months
Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score by Group - Phase II
Time frame: Baseline up to approximately 8 months
Everolimus Pharmacokinetic Plasma Concentrations - Phase II
Time frame: Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose

Results and safety

Results posted to the registry on 5 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A	8	0
Cohort B	10	0
Cohort C	7	0
Group 1	0	0
Group 2	0	0

Primary outcome: Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I

Time frame: Baseline up to 28 days. Count of participants. Unit: Participants

Measure	Cohort A n = 8	Cohort B n = 10	Cohort C n = 7
Febrile neutropenia Grade 3	1	1	0
Neutropenia Grade 4	0	1	0
Thrombocytopenia Grade 4	0	1	0
Cardiac tamponade Grade 4	1	0	0
Diarrhea Grade 3	1	0	0
Hyperglycemia Grade 4	0	0	1

Population analysed: dose limiting toxicity-determining set

Primary outcome: Clinical Benefit Rate as Per Central Review by Group- Phase II

Time frame: From baseline up to 24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1 n = 46	Group 2 n = 32
Overall response rate (CR+PR):	6.5 (1.4 to 17.9)	9.4 (2.0 to 25.0)
CBR - CR+PR+SD (NCRNPD) by 24 weeks	65.2 (49.8 to 78.6)	59.4 (40.6 to 76.3)
Disease control rate (CR+PR+SD(NCRNPD)	65.2 (49.8 to 78.6)	59.4 (40.6 to 76.3)

Population analysed: Protocol analysis set. n: Number of patients who are at the corresponding category. ORR: percentage of patients having BOR of CR/PR.

Primary outcome: Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II

Time frame: Baseline up to 24 weeks and at 24 weeks. Count of participants. Unit: Participants

Measure	Group 1 n = 46	Group 2 n = 32
Participants with measurable disease at baseline	35	21
Participants with non-measurable disease at baseline	11	11
Complete response (CR)	0	0
Partial Response (PR)	3	3
Stable disease (SD)	17	6
Progressive disease (PD)	14	12
NCRNPD - Non-complete response non-progressive disease	10	10
Unknown	2	1

Population analysed: Full analysis set

8 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A	3 of 8 (37.5%)	8 of 8 (100%)	6 of 8
Cohort B	3 of 10 (30%)	10 of 10 (100%)	5 of 10
Cohort C	5 of 7 (71.4%)	7 of 7 (100%)	0 of 7
Group 1	11 of 46 (23.9%)	46 of 46 (100%)	20 of 46
Group 2	5 of 33 (15.2%)	33 of 33 (100%)	11 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. his trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ribociclib, Everolimus and Exemestane in people with Breast Cancer, run by Novartis Pharmaceuticals at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I (time frame: Baseline up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.