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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05774951
Registration number
NCT05774951
Ethics application status
Date submitted
16/02/2023
Date registered
20/03/2023
Date last updated
7/08/2024
Titles & IDs
Public title
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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Scientific title
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
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Secondary ID [1]
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2022-501024-20-00
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Secondary ID [2]
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D8531C00002
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Universal Trial Number (UTN)
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Trial acronym
CAMBRIA-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Camizestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Active comparator: Arm A: standard endocrine therapy of investigator´s choice - Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
Experimental: Arm B: camizestrant - Camizestrant
Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally
Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label
Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered per local approved label
Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered per local approved label
Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered per local approved label
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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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Invasive breast cancer-free survival (IBCFS)
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Assessment method [1]
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IBCFS is defined as time from randomisation until date of first occurrence of:
* Invasive ipsilateral breast tumour recurrence (invasive IBTR)
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Invasive contralateral breast cancer
* Death attributable to any cause.
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Timepoint [1]
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Up to 10 years
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Secondary outcome [1]
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Invasive disease-free survival (IDFS)
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Assessment method [1]
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IDFS is defined as time from randomisation until date of first occurrence of one of the following events:
* Invasive ipsilateral breast tumor recurrence (invasive IBTR)
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Invasive contralateral breast cancer
* Second primary non-breast invasive cancer
* Death attributable to any cause.
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Timepoint [1]
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Up to 10 years
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Secondary outcome [2]
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Distant relapse-free survival (DRFS)
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Assessment method [2]
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DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
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Timepoint [2]
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Up to 10 years
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Secondary outcome [3]
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Overall survival (OS)
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Assessment method [3]
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OS is defined as time from randomisation until death from any cause.
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Timepoint [3]
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Up to 10 years
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Secondary outcome [4]
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Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
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Assessment method [4]
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0
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Timepoint [4]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [5]
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Absolute and percent change from baseline in Clinical Laboratory Parameters
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Assessment method [5]
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Timepoint [5]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [6]
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Absolute and percent change from baseline in Vital Sign Parameters
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Assessment method [6]
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Timepoint [6]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [7]
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Number of participants with abnormal physical examinations
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Assessment method [7]
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0
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Timepoint [7]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [8]
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Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [8]
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Timepoint [8]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [9]
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Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [9]
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Timepoint [9]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [10]
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Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [10]
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Timepoint [10]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [11]
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Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [11]
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0
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Timepoint [11]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [12]
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Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [12]
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0
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Timepoint [12]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [13]
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Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [13]
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0
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Timepoint [13]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [14]
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Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
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Assessment method [14]
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0
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Timepoint [14]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [15]
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Pharmacokinetics (PK)
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Assessment method [15]
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• Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
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Timepoint [15]
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Until 6 months from treatment start
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Eligibility
Key inclusion criteria
* Women and Men, =18 years at the time of screening (or per national guidelines)
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
* Eastern Cooperative Oncology Group (ECOG) performance status of = 1
* Adequate organ and marrow function
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Minimum age
18
Years
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Maximum age
130
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
Exclusion criteria:
* Inoperable locally advanced or metastatic breast cancer
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
* Known LVEF <50% with heart failure NYHA Grade =2.
* Mean resting QTcF interval >480 ms at screening
* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
* Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist
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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
Parallel
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Other design features
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Phase
Phase 3
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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
31/03/2023
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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
29/05/2036
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Actual
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Sample size
Target
4300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
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0
United States of America
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State/province [2]
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Alaska
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Country [3]
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0
United States of America
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State/province [3]
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Arizona
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Country [4]
0
0
United States of America
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State/province [4]
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Arkansas
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Country [5]
0
0
United States of America
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State/province [5]
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California
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Country [6]
0
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United States of America
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State/province [6]
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Colorado
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Country [7]
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United States of America
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State/province [7]
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Connecticut
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Country [8]
0
0
United States of America
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State/province [8]
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Florida
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Country [9]
0
0
United States of America
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State/province [9]
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Georgia
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Country [10]
0
0
United States of America
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State/province [10]
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Hawaii
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Country [11]
0
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United States of America
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State/province [11]
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Illinois
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Country [12]
0
0
United States of America
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State/province [12]
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Indiana
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Country [13]
0
0
United States of America
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State/province [13]
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Iowa
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Country [14]
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United States of America
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State/province [14]
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Kentucky
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Country [15]
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United States of America
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State/province [15]
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Louisiana
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Country [16]
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United States of America
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State/province [16]
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Maine
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Country [17]
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United States of America
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State/province [17]
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Maryland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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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
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
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Trial website
https://clinicaltrials.gov/study/NCT05774951
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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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
No information has been provided regarding IPD availability
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/NCT05774951
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