Advanced HR+/HER2- Breast CancerPhase 1/2NCT06726148
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
A Phase 1/2 study testing ECI830, ribociclib and fulvestrant in people with Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, run by Novartis Pharmaceuticals at 33 sites in 16 countries.
Trial summary
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- What is being tested?
- ECI830, ribociclib and fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 33 sitesin 16 countries
- Study dates
- 3 Apr 2025to 25 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Patients with one of the following indications:
- Phase I:
- HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
- Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
- Patients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.
Show all 10Show fewer
- Phase II:
- HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.
- Measurable disease as determined by RECIST v1.1.
- BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
Who cannot join
- Previous treatment with a CDK2 inhibitor at any time.
- Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.
- Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
- For the combination treatment:
- Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
Show all 10Show fewer
- Patients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.
- For patients with BC: Patient is concurrently using hormone replacement therapy.
- WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
33 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 16 countries
United States8 sites, 8 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Leonid Syrkin, +1 617 632 5136, LEONID_SYRKIN@DFCI.HARVARD.EDU
Antonio Giordano
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33901
Sarah Gwirtz, +1 941 377 9993, Sarah.Gwirtz@flcancer.com
Manish Patel
- Recruiting
MD Anderson Cancer Center Uni of Te
Houston, Texas, 77030
Ileana Gutierrez, +1 713 792 2848, ilgutierrez@mdanderson.org
Timothy Yap
- Recruiting
University of California LA
Los Angeles, California, 90095
Monica Rocha, +1 310 794 4376, mprocha@mednet.ucla.edu
Saeed Sadeghi
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Kristy Long, kristy.long@SCRI.com
Erika Paige Hamilton
- Recruiting
Memorial Sloan Kettering
New York, New York, 10017
Sam Stefanik, stefanis@mskcc.org
Komal Jhaveri
- Recruiting
Fred Hutch Cancer Research
Seattle, Washington, 98109
Ly Tieng Huot, +1 206288 1382, lhuot@fredhutch.org
Sara Hurvitz
- Recruiting
WA Uni School Of Med
St Louis, Missouri, 63110
Mary Halim, +1 314 362 7249, maryh@wustl.edu
Cynthia Ma
Germany3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Novartis Investigative Site
Heidelberg, 69120
- Recruiting
Novartis Investigative Site
Ulm, 89081
Australia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Clayton, Victoria, 3168
- Recruiting
Novartis Investigative Site
Melbourne, Victoria, 3004
Canada2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
China2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Nanjing, Jiangsu, 210029
- Recruiting
Novartis Investigative Site
Xian, Shanxi, 710061
Denmark2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Copenhagen, 2100
- Recruiting
Novartis Investigative Site
Odense C, 5000
France2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33076
- Recruiting
Novartis Investigative Site
Saint-Herblain, 44805
Israel2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Haifa, 3109601
- Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
Italy2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Milan, MI, 20141
- Recruiting
Novartis Investigative Site
Modena, MO, 41124
Spain2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Barcelona, 08036
Czechia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Brno, 656 53
Japan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
Singapore1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 119074
South Korea1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
United Kingdom1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
London, Oxford, OX3 7LE
About this study
Official title: An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Read the detailed description
This is a first-in-human, open-label, phase I/II, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+/HER2- breast cancer or other advanced solid tumors harboring CCNE1 amplification or extensive-stage small cell lung cancer (ES-SCLC), and a combination treatment arm of ECI830 with ribociclib and fulvestrant in patients with advanced breast cancer. Single agent escalation may be followed by an expansion part stratified by disease indication. The escalation of the combination arm may continue into a randomized, open label, Phase II with optional dose optimization in advanced breast cancer patients.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Being tested
- ECI830, ribociclib, fulvestrant
- Keywords
- ECI830, Ribociclib, Fulvestrant, Breast cancer, CCNE1 amplification, Small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECI830Drug
Experimental
ribociclibDrug
Also called Kisqali
Approved medication
fulvestrantDrug
Also called Faslodex
Approved medication
| Study group | Role | What they receive |
|---|---|---|
| ECI830 Single Agent (Arm A) | Experimental | Phase I Receives: Drug: ECI830 |
| Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) | Experimental | Phase I Receives: Drug: ECI830; Drug: ribociclib; Drug: fulvestrant |
| Ribociclib in combination with fulvestrant (Arm C) | Experimental | Phase II Receives: Drug: ribociclib; Drug: fulvestrant |
| ECI830 in combination with fulvestrant (Arm D) | Experimental | Phase II Receives: Drug: ECI830; Drug: fulvestrant |
| ECI830 in combination with ribociclib and fulvestrant (Arm E) | Experimental | Phase II Receives: Drug: ECI830; Drug: ribociclib; Drug: fulvestrant |
| ECI830 in combination with ribociclib and fulvestrant (Arm F) | Experimental | Phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of dose-limiting toxicities (DLTs)
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 2 years
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Measured: 2 years
Phase I: Number of participants with dose interruptions, reductions and discontinuations
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow patients to continue the study treatment.
Measured: 2 years
Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
Progression Free Survival (PFS) rate at 6 months is defined as the proportion of patients who are alive and progression-free per RECIST v1.1 at 6 months.
Measured: 6 months
Secondary outcomes (11)
Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
Pharmacokinetic (PK) parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
Measured: From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
PK parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
Measured: From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Best overall response (BOR) per RECIST v1.1
BOR per RECIST v1.1 is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first.
Measured: 2 years
Phase I and II: Overall response rate (ORR) per RECIST v1.1
ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR) according to RECIST v1.1 as per local review.
Measured: 2 years
Phase I and II: Disease control rate (DCR) per RECIST v1.1
DCR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or Stable disease (SD) according to RECIST v1.1 as per local review.
Measured: 2 years
Phase I and II: Clinical benefit rate (CBR) per RECIST v1.1
CBR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or an overall lesion response of SD or Non-CR/Non-PD which lasts for at least 24 weeks according to RECIST v1.1 as per local review.
Measured: 2 years
Phase I and II: Progression Free Survival (PFS) per RECIST v1.1
PFS is defined as the time from the date randomization to the date of the first documented progression or death due to any cause.
Measured: 2 years
Phase II: Duration of Response (DOR) per RECIST v1.1
DOR per RECIST v1.1 is the time between the first documented response (CR or PR) and the date of progression or death due to any cause.
Measured: 2 years
Phase II: Overall Survival (OS)
OS is defined as the time between the date of randomization to the date of death due to any cause.
Measured: 2 years
Phase II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Measured: 2 years
Phase II: Number of participants with dose interruptions, reductions and discontinuations
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow patients to continue the study treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start3 Apr 2025
- Primary completion25 Sep 2028 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HR+/HER2- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726148
- Sponsor's protocol ID
- CECI830A12101
- Other IDs
- 2024-517281-42
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06726148
- Acronym / sponsor ID
- CECI830A12101
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Keywords
- ECI830, Ribociclib, Fulvestrant, Breast cancer, CCNE1 amplification, Small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 25 Sep 2028 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Detailed description
This is a first-in-human, open-label, phase I/II, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+/HER2- breast cancer or other advanced solid tumors harboring CCNE1 amplification or extensive-stage small cell lung cancer (ES-SCLC), and a combination treatment arm of ECI830 with ribociclib and fulvestrant in patients with advanced breast cancer. Single agent escalation may be followed by an expansion part stratified by disease indication. The escalation of the combination arm may continue into a randomized, open label, Phase II with optional dose optimization in advanced breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ECI830 Single Agent (Arm A) | Experimental | Drug: ECI830Phase I |
| Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) | Experimental | Drug: ECI830, Drug: ribociclib, Drug: fulvestrantPhase I |
| Ribociclib in combination with fulvestrant (Arm C) | Experimental | Drug: ribociclib, Drug: fulvestrantPhase II |
| ECI830 in combination with fulvestrant (Arm D) | Experimental | Drug: ECI830, Drug: fulvestrantPhase II |
| ECI830 in combination with ribociclib and fulvestrant (Arm E) | Experimental | Drug: ECI830, Drug: ribociclib, Drug: fulvestrantPhase II |
| ECI830 in combination with ribociclib and fulvestrant (Arm F) | Experimental | –Phase II |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old.
- HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
- Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
- Patients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.
- HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.
Key exclusion criteria (10 listed)
- Previous treatment with a CDK2 inhibitor at any time.
- Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.
- Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
- Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
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 |
|---|---|---|
| ECI830Experimental | Drug | Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B), ECI830 Single Agent (Arm A), ECI830 in combination with fulvestrant (Arm D), ECI830 in combination with ribociclib and fulvestrant (Arm E) |
| ribociclibAlso: KisqaliApproved medication | Drug | Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B), ECI830 in combination with ribociclib and fulvestrant (Arm E), Ribociclib in combination with fulvestrant (Arm C) |
| fulvestrantAlso: FaslodexApproved medication | Drug | Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B), ECI830 in combination with fulvestrant (Arm D), ECI830 in combination with ribociclib and fulvestrant (Arm E), Ribociclib in combination with fulvestrant (Arm C) |
Primary outcome
Phase I: Incidence of dose-limiting toxicities (DLTs)
Time frame: 2 years
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 2 years
Number of participants with AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Phase I: Number of participants with dose interruptions, reductions and discontinuations
Time frame: 2 years
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow patients to continue the study treatment.
Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
Time frame: 6 months
Progression Free Survival (PFS) rate at 6 months is defined as the proportion of patients who are alive and progression-free per RECIST v1.1 at 6 months.
11 secondary outcomes
Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
Time frame: From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
Time frame: From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Best overall response (BOR) per RECIST v1.1
Time frame: 2 years
Phase I and II: Overall response rate (ORR) per RECIST v1.1
Time frame: 2 years
Phase I and II: Disease control rate (DCR) per RECIST v1.1
Time frame: 2 years
Phase I and II: Clinical benefit rate (CBR) per RECIST v1.1
Time frame: 2 years
Phase I and II: Progression Free Survival (PFS) per RECIST v1.1
Time frame: 2 years
Phase II: Duration of Response (DOR) per RECIST v1.1
Time frame: 2 years
Phase II: Overall Survival (OS)
Time frame: 2 years
Phase II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 2 years
Phase II: Number of participants with dose interruptions, reductions and discontinuations
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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. This 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.
33 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ECI830, ribociclib and fulvestrant in people with Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, run by Novartis Pharmaceuticals at 33 sites in 16 countries.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Australia, Canada, China and 11 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of dose-limiting toxicities (DLTs) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.