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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06726148
Registration number
NCT06726148
Ethics application status
Date submitted
5/12/2024
Date registered
10/12/2024
Date last updated
29/06/2025
Titles & IDs
Public title
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
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Scientific 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
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Secondary ID [1]
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2024-517281-42
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Secondary ID [2]
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CECI830A12101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced HR+/HER2- Breast Cancer
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Advanced CCNE1-amplified Solid Tumors
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ECI830
Treatment: Drugs - ribociclib
Treatment: Drugs - fulvestrant
Experimental: ECI830 Single Agent (Arm A) - Phase I
Experimental: Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) - Phase I
Experimental: Ribociclib in combination with fulvestrant (Arm C) - Phase II
Experimental: ECI830 in combination with fulvestrant (Arm D) - Phase II
Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm E) - Phase II
Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm F) - Phase II
Treatment: Drugs: ECI830
Experimental
Treatment: Drugs: ribociclib
Approved medication
Treatment: Drugs: fulvestrant
Approved medication
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase I: Incidence of dose-limiting toxicities (DLTs)
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Primary outcome [2]
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Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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2 years
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Primary outcome [3]
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Phase I: Number of participants with dose interruptions, reductions and discontinuations
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Primary outcome [4]
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Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
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Assessment method [4]
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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.
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Timepoint [4]
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6 months
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Secondary outcome [1]
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Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
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Assessment method [1]
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Pharmacokinetic (PK) parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
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Timepoint [1]
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From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
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Secondary outcome [2]
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Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
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Assessment method [2]
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PK parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
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Timepoint [2]
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From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
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Secondary outcome [3]
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Phase I and II: Best overall response (BOR) per RECIST v1.1
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Phase I and II: Overall response rate (ORR) per RECIST v1.1
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Assessment method [4]
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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.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Phase I and II: Disease control rate (DCR) per RECIST v1.1
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Assessment method [5]
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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.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Phase I and II: Clinical benefit rate (CBR) per RECIST v1.1
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Assessment method [6]
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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.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Phase I and II: Progression Free Survival (PFS) per RECIST v1.1
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Assessment method [7]
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PFS is defined as the time from the date randomization to the date of the first documented progression or death due to any cause.
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Phase II: Duration of Response (DOR) per RECIST v1.1
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Assessment method [8]
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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.
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Phase II: Overall Survival (OS)
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Assessment method [9]
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OS is defined as the time between the date of randomization to the date of death due to any cause.
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Timepoint [9]
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2 years
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Secondary outcome [10]
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Phase II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [10]
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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.
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Phase II: Number of participants with dose interruptions, reductions and discontinuations
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Assessment method [11]
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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.
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Timepoint [11]
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2 years
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Eligibility
Key inclusion criteria
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.
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.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/09/2028
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Actual
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Sample size
Target
280
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Clayton
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Tennessee
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Israel
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State/province [5]
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Haifa
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Country [6]
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Israel
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State/province [6]
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Tel Aviv
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Country [7]
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Japan
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State/province [7]
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Tokyo
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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Singapore
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State/province [9]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06726148
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06726148
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